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更新于：2026-08-13

Ipilimumab

伊匹木单抗

更新于：2026-08-13

概要

基本信息

药物类型

单克隆抗体

别名

Anti CTLA-4 monoclonal antibody、Anti-CTLA-4 Mab、Ipilimumab (Genetical Recombination)

+ [17]

靶点

CTLA4

作用方式

抑制剂

作用机制

CTLA4抑制剂(细胞毒性T淋巴细胞相关抗原4抑制剂)

治疗领域

肿瘤消化系统疾病呼吸系统疾病+ [11]

在研适应症

微卫星高度不稳定性直肠癌PD-L1阳性非小细胞肺癌转移性肝细胞癌+ [265]

非在研适应症

急性双系白血病急性双表型白血病复发性急性淋巴细胞白血病+ [154]

原研机构

Bristol Myers Squibb Co.

在研机构

National Cancer Institute

Bristol Myers Squibb Co.

The University of Texas MD Anderson Cancer Center

+ [17]

非在研机构

Personal Genome Diagnostics, Inc.

The University of Texas Southwestern Medical Center

Fred Hutchinson Cancer Research Center

+ [11]

权益机构

Nektar Therapeutics

Inspirna, Inc.

Nexoplex Bio, Inc.

+ [8]

最高研发阶段批准上市

首次获批日期

美国 (2011-03-25),

黑色素瘤

最高研发阶段(中国)批准上市

特殊审评快速通道 (美国)、加速批准 (美国)、孤儿药 (美国)、孤儿药 (日本)、孤儿药 (韩国)、突破性疗法 (中国)、优先审评 (澳大利亚)、优先审评 (美国)、附条件批准 (中国)、优先审评 (中国)、突破性疗法 (美国)

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结构/序列

Sequence Code 143797L

来源: *****

Sequence Code 9060585H

来源: *****

关联

920

项与伊匹木单抗相关的临床试验

NCT07587827

/ Not yet recruiting临床1期IIT

A Phase 1, Open-label, Dose-escalation and Dose-expansion Study Evaluating the Safety Feasibility and Efficacy of ODI-2001 Vaccine, a Personnalized Immunotherapy in Patients With Metastatic or Locally Advanced Colon Cancer or Pancreatic Cancer

This is a phase 1, open-label, multicentric study evaluating the safety, feasibility and efficacy of ODI-2001, a personnalized therapeutic cancer vaccine composed of DNA neoantigen vaccine, Modified Vaccinia virus Ankara (MVA) viral adjuvant and anti-CTLA4 (ipilimumab), in patients with metastatic or locally advanced colorectal or pancreatic cancer. The study includes a dose-escalation phase to determine the maximum tolerated dose (MTD) followed by an expansion phase to evaluate efficacy in terms of progression-free survival

开始日期2026-11-01

申办/合作机构

Centre Georges François Leclerc

NCT07689175

/ Not yet recruiting临床2期IIT

Phase 2 Trial of Adaptive Dosing of Immune Checkpoint Inhibitors for Unresectable Child Pugh B Hepatocellular Carcinoma

The goal of this clinical trial is to learn if immunotherapy including nivolumab plus ipilimumab is effective and safe in treating hepatocellular carcinoma.

开始日期2026-10-31

申办/合作机构

The University of Texas Southwestern Medical Center

[+1]

NCT07511036

/ Not yet recruiting临床2期IIT

PROSECCO: A Phase 2, Single Arm, Neoadjuvant Study Evaluating Combination Cemiplimab, Fianlimab, And Ipilimumab In Patients With Surgically Resectable Melanoma

This is a phase II study testing the safety and preliminary efficacy of triplet ICB in treatment naïve patients with clinical stage III or oligometastatic stage IV melanoma with resectable disease.

开始日期2026-09-01

申办/合作机构

The University of Texas MD Anderson Cancer Center

100 项与伊匹木单抗相关的临床结果

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100 项与伊匹木单抗相关的转化医学

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100 项与伊匹木单抗相关的专利（医药）

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5,449

项与伊匹木单抗相关的文献（医药）

2026-12-31·CNS oncology

Tailored management of a melanoma patient with bleeding brain metastases and deep vein thrombosis with thrombectomy

Article

作者: Ceccarelli, Corrado ; Pastina, Ilaria ; Del Roscio, Davide ; Viterbo, Antonella ; De Angelis, Filippo ; Pieraccini, Massimo ; Arezzini, Luca

CASE PRESENTATION:

We describe a 62-year-old man with disseminated melanoma (initially staged pT2aN0M0, AJCC stage IB, 8th edition AJCC) who developed multiple brain metastases with hemorrhagic transformation, pulmonary embolism, retrobulbar progression with eyeball herniation, and deep vein thrombosis (DVT). After cerebral edema improved with corticosteroid tapering and the patient became asymptomatic, he started combination immunotherapy with ipilimumab (3 mg/kg q3w × 4) and nivolumab (1 mg/kg q3w × 4). Despite initial benefit, progression led to radiotherapy for retrobulbar lesion and subsequent targeted therapy with encorafenib (450 mg daily) and binimetinib (45 mg twice daily). Shortly after, the patient developed symptomatic left-leg DVT extending to the femoral vein with segmental pulmonary embolism. Given the contraindication to full anticoagulation, mechanical thrombectomy with the Indigo Aspiration System was performed, followed by prophylactic LMWH at reduced therapeutic dose (enoxaparin 1 mg/kg once daily due to recent thrombectomy and hemorrhagic risk from bleeding brain metastases). During targeted therapy, the patient experienced partial regression of brain, liver, and peritoneal metastases, although intracranial hemorrhage recurred later.

CONCLUSIONS:

This case highlights the value of a multidisciplinary, tailored approach integrating immunotherapy, radiotherapy, targeted therapy, and mechanical thrombectomy with no DVT recurrence observed following thrombectomy at 6-month follow-up.

2026-12-01·JOURNAL OF BIOMOLECULAR NMR

A fast and efficient strategy for the NMR assignment of Fab methyl groups

Article

作者: Henot, Faustine ; Doyen, Camille ; Frances, Oriane ; Güntert, Peter ; Crublet, Elodie ; Vibert, Béatrice ; Giraud, Arthur ; Dbira, Sarra ; Favier, Adrien ; Imbert, Lionel ; Boisbouvier, Jérôme ; Clavier, Séverine

Owing to their high specificity and therapeutic effectiveness, monoclonal antibodies (mAbs) have rapidly become one of the leading classes of biologic drugs used to treat critical illnesses. The antigen-binding fragment (Fab) of mAbs plays a key role in the antigen recognition, so its structural characterization is essential, as even a slight change to its Higher Order Structure (HOS) can impact the antibody's potency. Recently, 2D methyl NMR has been introduced as a powerful method to assess both the structure and integrity of therapeutic Fab fragments. However, the identification of methyl group resonances in NMR spectra remains rare since Fabs are large heterodimers of ~ 50 kDa. Here, we present the methyl group assignment of an IgG1 Fab produced in a cell-free system with an optimal isotope labelling. We first assigned 99% of the alanine, isoleucine, leucine, methionine, and valine methyl groups of the therapeutic Fab targeting LAMP1 antigen. Building on this assignment, we propose a "divide and conquer" strategy that exploits sequence identities to rapidly assign methyl groups of other IgG1 Fabs. We demonstrate that the assignment of the Fab's constant region can easily be transferred from one IgG1 to another and that the variable part of a new Fab can be assigned using smaller uniformly ¹⁵N,¹³C-labelled constructs. We applied our strategy to ipilimumab's Fab and, using the assignment of ipilimumab's variable part and Fab anti-LAMP1's constant part, we could transfer the assignment of 89% of the methyl-containing amino acids to the entire ipilimumab Fab without having to produce deuterated samples. This assignment strategy can be generalised to any other IgG1 Fabs provided that their constant regions are identical and the strategy can be adapted to accommodate the expression levels of the different variable domains. This new method drastically facilitates the Fab assignment process, making it suitable for the pharmaceutical timeline.

2026-08-01·SEMINARS IN ONCOLOGY

Risk of intensive care unit admission after immune checkpoint inhibitor use in cancer

Article

作者: Guarin, Geneva ; Bhandari, Sambhawana ; Baral, Maun R ; Ranganathan, Prabha ; McEvoy, Colleen ; Morgensztern, Daniel

Immune checkpoint inhibitors (ICIs) have transformed cancer therapy but can cause excessive immune activation, leading to severe adverse events, including intensive care unit (ICU) admission. Existing evidence on critical illness after ICI use is limited, largely single center, and focused on immune related adverse events. This study evaluates the risk of inpatient and ICU admissions after ICI initiation using two large national databases. We retrospectively analyzed MarketScan Commercial and Multi-state Medicaid Research Databases (2016-2022) to identify adults with solid organ malignancies treated with ICIs and determined if ICU admission was required within 90 days of ICI administration. The primary diagnosis for ICU admission was identified and categorized. Associations between cancer type, ICI type, and ICU admission were analyzed. About 33,040 patients received ICIs during the study period. About 48.9% were male and 51.1% female. Pembrolizumab was the most used (49.3%), followed by nivolumab (31.9%), and ipilimumab (9.4%). Lung cancer was the most common malignancy (40.8%), followed by genitourinary (16%), melanoma (13%), gastrointestinal (12%), and breast (10%). About 22.0% (n = 7,216) of patients were hospitalized, and 8.7% (n = 2,872) required ICU admission. Infection was the most frequent reason for ICU admission, followed by respiratory causes. The odds of being admitted to the ICU were higher with combination ICI (OR = 1.51, P < .001) compared to ICI monotherapy. In conclusion, among patients with solid organ malignancies, nearly 9% required ICU admission within 90 days of ICI initiation, most commonly for infectious causes. These findings highlight the need for heightened vigilance for critical illness in patients treated with ICIs.

2,278

项与伊匹木单抗相关的新闻（医药）

2026-08-12

·普外医学文献

综述|免疫检查点抑制剂在胃癌治疗中的应用现状——陈劲松雷雪涛董毅

作者陈劲松雷雪涛董毅 ▲通讯作者：陈劲松教授单位广州医科大学附属第一医院胃肠外科基金项目国家自然科学基金项目（82072620）；广东省基础与应用基础研究基金项目（2026A1515012582）引用本文陈劲松, 雷雪涛, 董毅. 免疫检查点抑制剂在胃癌治疗中的应用现状[J/OL]. 中华普通外科学文献(电子版), 2026, 20(3): 200–206. DOI：10.3877/cma.j.issn.1674-0793.2026.03.010 文章下载：陈劲松, 雷雪涛, 董毅. 免疫检查点抑制剂在胃癌治疗中的应用现状.pdf 【摘要】胃癌是人类最常见的恶性肿瘤之一，也是癌症相关死亡的常见原因。近年来，免疫检查点抑制剂（ICIs）的出现改变了胃癌的治疗格局。程序性死亡受体1/配体1（PD-1/PD-L1）抑制剂不仅在晚期胃癌一线治疗中显示出显著的生存获益，也为局部进展期胃癌的围手术期治疗提供了新策略。本文旨在探究ICIs在胃癌一线治疗及围手术期治疗中的应用，并探讨其耐药机制、免疫相关不良反应管理、肿瘤微环境异质性等关键问题，为新型免疫治疗策略开发、联合治疗方案优化及精准个体化治疗模式提供新思路。【关键词】胃肿瘤；免疫治疗；免疫检查点抑制剂；生物标志物；肿瘤微环境【正文】胃癌的发病率和死亡率在我国都居于恶性肿瘤第三位，并且大多数患者确诊时已处于进展期［1］。手术治疗是局部进展期胃癌的主要治疗手段，但由于胃癌的强异质性且术后复发和转移风险较高，单纯手术治疗效果有限。放化疗虽可在一定程度上延长患者生存期，但不良反应大，对于晚期患者的疗效不尽理想［2］。随着肿瘤治疗领域研究的深入，免疫检查点抑制剂（immune checkpoint inhibitors，ICIs）治疗成为继化疗和靶向治疗后的重大突破，通过逆转肿瘤免疫抑制的微环境，激活内源性抗肿瘤免疫反应，已成为胃癌综合治疗的重要组成部分［3］。近年来，ICIs治疗在胃癌中的应用迅速推进，从后线逐步拓展到一线、从晚期到围手术期。多项Ⅲ期临床研究，如CheckMate-649、KEYNOTE-859、RATIONALE-305等均证实，程序性死亡受体1（programmed cell death protein 1，PD-1）抑制剂联合化疗在晚期胃癌一线治疗中相比单纯化疗，可显著延长患者的总生存期（overall survival，OS）和无进展生存期（progression-free survival，PFS），且安全性可控。此外，在局部进展期胃癌的围手术期治疗中，ICIs也显示出较高的病理完全缓解（pathological complete response，pCR）率和主要病理缓解（major pathologic response，MPR）率，为改善患者预后提供新途径。但是，ICIs治疗在胃癌中的应用仍面临诸多挑战。不同分子分型的胃癌对ICIs治疗响应差异显著，原发性耐药与继发性耐药现象常见，免疫相关不良反应（immune-related adverse events，irAEs）的管理复杂，以及获益人群的精准筛选尚未统一等问题亟待解决。本文旨在系统梳理胃癌ICIs治疗的现状，剖析当前临床实践中存在的问题，并对未来发展方向进行展望。一、胃癌ICIs治疗的进展（一）晚期胃癌一线治疗的突破与传统化疗和靶向治疗直接攻击癌细胞不同，ICIs治疗的核心是通过激活或增强机体自身的免疫系统，恢复免疫细胞对癌细胞的识别和杀伤能力［3］。随着肿瘤免疫学的不断深入，ICIs治疗被证明在晚期胃癌一线治疗中具有显著成效。多项大型Ⅲ期临床研究为PD-1抑制剂联合化疗作为晚期胃癌一线治疗方案提供了高级别循证医学依据。 CheckMate-649是一项全球Ⅲ期临床试验，评估了纳武利尤单抗联合化疗对比单纯化疗在人表皮生长因子受体2（human epidermal growth factor receptor 2，HER-2）阴性晚期胃癌、食管胃结合部癌（gastroesophageal junction cancer，GEJC）和食管腺癌一线治疗中的疗效和安全性。结果显示，在细胞程序性死亡配体1（programmed cell death 1-ligand 1，PD-L1）联合阳性评分（combined positive score，CPS）≥5分的患者中，纳武利尤单抗联合化疗组的中位OS显著延长（14.4个月比11.1个月，HR=0.71，P<0.000 1），且在全人群中也有显著获益［4］。此后，KEYNOTE-859（2023）研究了帕博利珠单抗联合化疗对比安慰剂联合化疗在HER-2阴性晚期胃癌一线治疗中的疗效。结果显示，在意向治疗人群中，帕博利珠单抗组的中位OS显著优于安慰剂组（15.9个月比12.2个月，HR=0.68，95% CI：0.50~0.91），24个月OS率分别为33.0%和21.7%，且在PD-L1 CPS≥1分和CPS≥10分的人群中获益更加显著［5］。首个基于中国人群的胃癌一线ICIs治疗Ⅲ期临床试验ORIENT-16研究结果证实，信迪利单抗联合化疗显著改善了胃癌患者的OS，总人群OS延长了2.9个月（15.2个月比12.3个月，HR=0.68），死亡风险降低32%；PD-L1 CPS≥5分的人群OS延长6.3个月（19.2个月比12.9个月，HR=0.59），死亡风险降低41%［6］。RATIONALE-305研究探索了替雷利珠单抗联合化疗用于局部晚期不可切除或转移性胃癌一线治疗的疗效与安全性，该研究纳入全球多个国家/地区的997例晚期胃癌患者，结果显示在意向治疗人群中，替雷利珠单抗联合化疗的中位OS延长至15个月，显著优于安慰剂联合化疗组的12.9个月（HR=0.80，P=0.001），降低约20%的死亡风险；并且，PD-L1肿瘤区域阳性评分（tumor area positivity score，TAP）≥5%的受试者使用替雷利珠单抗联合化疗与安慰剂联合化疗相比，中位OS显著改善（17.2个月比12.6个月；HR=0.74，95% CI：0.59~0.94，P=0.006）［7］。此外，国产ICIs如卡瑞利珠单抗及卡度尼利单抗（COMPASSION-15研究）等也显示出类似的生存获益［6,8］。这些研究均表明，ICIs联合化疗在HER-2阴性晚期胃癌一线治疗中显著改善OS，并且PD-L1高表达患者获益更为显著，共同推动了免疫联合化疗成为HER-2阴性晚期胃癌一线治疗的全球共识与区域标准。（二）围手术期ICIs治疗探索随着ICIs治疗在晚期胃癌中取得突破性进展，研究者开始探索其在局部进展期胃癌围手术期治疗中的应用价值。多项临床研究聚焦于ICIs联合化疗作为新辅助或辅助治疗的疗效和安全性。 KEYNOTE-585研究评估了帕博利珠单抗联合化疗在局部晚期胃癌/GEJC围手术期治疗中的疗效。结果显示与单纯化疗相比，帕博利珠单抗联合化疗可显著提高pCR率，绝对差异为10.9%（12.9%比2.0%，P<0.000 01），但并未显著改善无事件生存期（event-free survival，EFS）［9］。DRAGON Ⅳ（CAP-05）研究首次在围手术期治疗中探索了卡瑞利珠单抗联合阿帕替尼及化疗的综合方案，结果显示其pCR率可达18.3%，显著优于单纯化疗［10］。2025年美国临床肿瘤学会（American Society of Clinical Oncology，ASCO）年会上公布了MATTERHORN研究结果，该研究评估了度伐利尤单抗联合FLOT方案（5-氟尿嘧啶、亚叶酸钙、奥沙利铂和多西他赛）在可切除胃食管腺癌围手术期治疗中的疗效。结果显示，度伐利尤单抗联合FLOT方案可显著提高胃癌患者pCR率，绝对差异为12%（19%比7%；OR=3.08，95% CI: 2.03~4.67；P<0.000 01），不仅改善了EFS（未达到比32.8个月，HR=0.71），OS也呈现出获益趋势。对于微卫星高度不稳定（microsatellite instability-high，MSI-H）或错配修复功能缺陷（deficient mismatch repair，dMMR）型局部进展期胃癌，ICIs治疗表现出尤其显著的疗效［11］。我国NICE研究的队列C评估了特瑞普利单抗联合CapeOX方案（卡培他滨+奥沙利铂）用于局部晚期dMMR/MSI-H型胃癌/GEJC围手术期治疗的疗效和安全性，结果显示，15例接受手术的患者均实现R0切除，MPR率达93.3%，pCR率达80%，中位随访22.5个月，未出现疾病复发，1年OS率达93.8%［12］。国产PD-1抑制剂在围手术期治疗中也展现出应用潜力。WuhanUHGI001研究探索替雷利珠单抗联合SOX方案（替吉奥+奥沙利铂）作为新辅助治疗方案用于进展期胃癌/GEJC Ⅱ期，结果显示，疾病控制率（disease control rate，DCR）为90.6%，MPR率为53.1%，pCR率为25%，且不增加治疗相关不良事件［13］。此外，NEOSUMMIT-03研究评估了替雷利珠单抗联合SOX化疗方案在局部晚期GEJC患者围手术期治疗中的疗效和安全性，结果显示R0切除率为96.9%，MPR率达到50.0%，pCR率为28.1%，18个月的OS、EFS率分别达到84.4%和74.4%［14］。这些研究结果表明，ICIs在局部进展期胃癌围手术期治疗中具有重要应用价值，尤其对于dMMR/MSI-H型患者效果显著，为提高局部进展期胃癌患者pCR率提供了新治疗策略。二、生物标志物与个体化治疗胃癌是一种高度异质性的疾病，不同分子分型对ICIs治疗的响应存在显著差异。因此，寻找可靠的预测性生物标志物，对于实现精准个体化ICIs治疗、最大化治疗获益至关重要。（一） PD-L1表达 PD-L1与PD-1结合可激活免疫抑制信号通路，进而抑制T细胞功能并促进肿瘤细胞的免疫逃逸。PD-L1蛋白是目前应用最广泛的ICIs治疗生物标志物。多项研究显示，胃癌PD-L1高表达患者从ICIs治疗中获益更显著。CheckMate-649研究中，纳武利尤单抗联合化疗在PD-L1 CPS≥5分的患者中获益最为显著，对比单纯化疗组中位OS延长3.3个月（14.4个月比11.1个月，HR=0.71，98.4% CI：0.59~0.86），在CPS≥1分的患者中也有显著获益（HR=0.77），但在CPS<1分的患者中未能显著改善OS（HR=0.92）。基于这一数据，美国FDA肿瘤药物咨询委员会建议将PD-1抑制剂仅用于PD-L1 CPS≥1分的胃癌患者［4］。我国ORIENT-16研究证实了信迪利单抗联合化疗一线治疗晚期胃癌或GEJC，能够为全人群及PD-L1 CPS≥5分的患者带来具有统计学意义和临床意义的OS和PFS改善，且安全性可控［15］。基于ORIENT-16优秀的研究数据，信迪利单抗获得国家药品监督管理局批准，联合化疗方案用于晚期胃癌的一线治疗。然而，PD-L1表达对胃癌ICIs治疗反应的预测价值仍存在局限性。首先，PD-L1表达具有时空异质性，原发灶与转移灶、治疗前后均可出现表达差异；其次，不同检测平台、抗体和判读标准可能导致结果不一致。相关专家共识推荐在胃癌中使用22C3、28-8抗体（基于Dako Autostainer Link 48平台）及SP263抗体（基于Ventana BenchMark平台）进行PD-L1免疫组织化学检测，其中22C3已获FDA批准用于评估胃癌患者接受pembrolizumab治疗的适应性［16］。但不同抗体克隆间检测结果的可比性仍有限，研究显示28-8抗体所得PD-L1 CPS评分较22C3抗体可高出近1倍［17］，提示检测体系差异可能导致患者分层不一致。判读方面，相对于仅评估肿瘤细胞中PD-L1阳性细胞所占TAP，同时将肿瘤细胞、淋巴细胞及巨噬细胞中PD-L1阳性细胞计入评分的CPS评分更能反映肿瘤免疫微环境特征，亦在多项临床试验（如KEYNOTE系列）中被证实具有更高的预测价值。因此，PD-L1不应作为唯一筛选标准，应结合MSI、肿瘤突变负荷（tumor mutation burden，TMB）等指标综合评估［18］。（二） MSI-H/dMMR状态 MSI-H或dMMR是胃癌ICIs治疗强有力的预测生物标志物。研究表明，5%~20%的胃癌/GEJC患者为dMMR/MSI-H表型，其具有高TMB、新生抗原丰富和免疫细胞浸润程度高等特点，对PD-1抑制剂高度敏感［19］。在KEYNOTE-062研究中，帕博利珠单抗单药治疗MSI-H晚期胃癌的客观缓解率（objective remission rate，ORR）高达57.1%，而化疗组仅为36.8%［20］。在围手术期治疗中，NEONIPIGA研究显示约59%的MSI-H/dMMR型胃癌患者接受新辅助纳武利尤单抗联合伊匹木单抗治疗后达到pCR［21］。NCCN指南推荐，术前使用纳武利尤单抗联合伊匹木单抗、单药帕博利珠单抗或曲美木单抗联合度伐利尤单抗治疗MSI-H/dMMR型胃癌患者。基于这些数据，MSI-H/dMMR状态已成为胃癌ICIs治疗的重要选择标准。（三）其他生物标志物 TCGA分子分型将胃食管癌分为4大亚型：染色体不稳定型（chromosomal instability，CIN）、基因组稳定型（genomically stable，GS）、MSI和EB病毒（epstein-barr virus，EBV）感染型，其比例分别为70%、20%、5%和5%。EBV感染型胃癌通常具有PD-L1高表达、CD8+ T细胞浸润程度高和免疫激活等特点，对ICIs治疗较为敏感［19］。此外，其他分子特征如HER-2表达水平、Claudin 18.2表达状态、FGFR2b过表达（约30%）等也具有预测价值，并可指导靶向治疗与ICIs治疗的联合策略。例如，KEYNOTE-811研究显示，帕博利珠单抗+曲妥珠单抗+化疗用于HER-2阳性晚期胃癌一线治疗的ORR高达74.4%［22］。循环肿瘤DNA（circulating tumor DNA，ctDNA）检测为微小残留病灶（minimal residual disease，MRD）监测和个体化辅助ICIs治疗提供了新策略。2025年ASCO年会上，研究人员揭晓了对术后ctDNA阳性的MSI-H实体瘤患者使用帕博利珠单抗辅助治疗的结果，发现ctDNA阴性队列的24个月无复发生存（relapse-free survival，RFS）率达94%，而ctDNA阳性并接受帕博利珠单抗辅助治疗的队列24个月RFS率为64%，显著优于未治疗即复发组（0）。此外，接受帕博利珠单抗辅助治疗的患者中，6个月ctDNA清除率为85%，9个月时达100%。这些结果表明，ctDNA监测可用于识别高危患者并指导辅助ICIs治疗，但值得注意的是，尽管ctDNA清除率很高，仍有38%的患者在ctDNA转阴后出现影像学复发，提示需要进一步优化治疗方案［23］。三、当前面临的挑战与问题尽管ICIs治疗为胃癌患者带来了新希望，但其临床应用仍面临诸多挑战，包括原发性和继发性耐药、irAEs、肿瘤微环境（tumor microenvironment，TME）异质性等问题。（一）原发性与继发性耐药机制耐药性是胃癌ICIs治疗面临的主要挑战。原发性耐药指患者初始对ICIs治疗无响应；而继发性耐药指初始响应后，随着时间的推移出现疗效下降或完全失效。弥漫型胃癌（diffuse-type gastric cancer，DGC）侵袭性强、预后差，对ICIs治疗普遍耐药，其发生率是肠型胃癌的2倍，这主要源于DGC形成了抑制性免疫微环境，具体机制包括：免疫抑制细胞，如调节性T细胞（regulatory T cells，Tregs）、髓源性抑制细胞、M2型巨噬细胞浸润，分泌转化生长因子β等因子形成“冷肿瘤”；肿瘤细胞抗原提呈缺陷（如MHC-Ⅰ分子下调）、信号通路异常（γ干扰素信号通路突变导致T细胞功能异常和PD-1表达缺失；MAPK通路异常激活影响T细胞增殖和功能；Wnt/β-catenin通路激活导致T细胞浸润减少和免疫逃逸）、肿瘤间质屏障（转化生长因子β等因子激活的肿瘤相关成纤维细胞分泌胶原蛋白、纤连蛋白等细胞外基质成分，形成物理屏障并分泌免疫CXCL12、CCL2、CSFs等抑制因子）等［24-26］。此外，肠道菌群与代谢重编程在胃癌的发生过程中具有重要作用，并影响患者对ICIs治疗的反应。幽门螺杆菌可能通过上调胃上皮PD-L1表达、抑制CD4+ T细胞增殖及白细胞介素-2、γ干扰素的产生，直接诱导耐药；寡养单胞菌属、月形单胞菌属和TME中BDCA2+浆细胞样树突状细胞（plasmacytoid dendritic cells，pDCs）及Foxp3+ Tregs丰度呈正相关，可共同诱导形成免疫抑制微环境。癌细胞中糖酵解重编程限制了抗肿瘤免疫应答，其可导致胃癌细胞大量消耗葡萄糖并产生乳酸，效应T细胞因“饥饿”和酸性环境抑制而功能受损，并且乳酸可对PD-L1蛋白进行乳酸化修饰，增强其稳定性，从而更有效地“关闭”T细胞活性［26-28］。（二） irAEs的管理 ICIs通过解除PD-1/PD-L1等免疫检查点的抑制作用，在激活T细胞抗肿瘤效应的同时，可能引发多器官的自身免疫样反应，导致irAEs。irAEs可影响全身多个器官系统，最常见的依次为皮肤、胃肠道、内分泌系统和肝脏［29］。15%~30%的患者在ICIs治疗早期（多于给药后6周内）会出现皮疹或瘙痒，其中抗细胞毒性T淋巴细胞相关抗原4（cytotoxic T lymphocyte antigen-4, CTLA-4）药物诱发的发生率高于抗PD-1药物，典型表现为躯干及四肢对称性红斑，病理学上表现为CD4+ T细胞浸润的界面性皮炎。在消化系统方面，免疫性结肠炎常见于CTLA-4抑制剂（10%~20%），表现为水样腹泻、血性黏液便，内镜可见黏膜充血、水肿及糜烂；而PD-1/PD-L1抑制剂则更易引发肝炎（5%~10%），表现为转氨酶升高（ALT/AST>3×ULN）或进展性黄疸，病理学常见门静脉区或小叶性淋巴细胞浸润。甲状腺是内分泌系统中最易受累的器官，常表现为甲状腺炎继发的甲状腺功能减退；而垂体功能减退虽少见（1%~3%），但可能导致危及生命的肾上腺危象［30-31］。在呼吸系统方面，免疫相关性肺炎总体发生率为1%~2%，表现为低氧血症与弥散功能下降，高分辨率CT可见双侧磨玻璃影伴小叶间隔增厚，需与感染或肿瘤进展相鉴别［32］。总体而言，在对症支持治疗的同时，irAEs的处理应强调早期识别与分级、及时停药和以糖皮质激素为核心的免疫抑制治疗，并结合器官特异性毒性选择二线免疫抑制剂或长期替代治疗。（三） TME异质性对胃癌ICIs治疗的挑战胃癌TME的高度异质性是ICIs治疗面临的另一挑战。TME包含多种免疫细胞、细胞因子和基质成分，其中肿瘤浸润淋巴细胞（tumor-infiltrating lymphocytes，TILs）和肿瘤相关巨噬细胞（tumor-associated macrophages，TAMs）是重要组成部分。 TILs主要由CD4+辅助性T细胞、CD8+细胞毒性T细胞和Tregs构成，其数量和活化状态与患者预后相关。TAMs根据极化状态分为M1和M2表型，M1型巨噬细胞具有抗肿瘤活性，M2型巨噬细胞则促进肿瘤生长并抑制免疫反应［25,33］。Zeng等［34］依据TME中免疫细胞和基质细胞的组成、比例及功能状态，开发机器学习工具TME classifier，将胃癌TME分为3种亚型：免疫排斥型（immune-excluded，IE）、免疫抑制型（immune-suppressed，IS）和免疫激活型（immune-activated，IA），揭示了TME异质性与ICIs治疗反应的密切关联。其中，IE亚型以基质细胞富集为特征，与侵袭性表型和ICIs治疗抵抗相关；IS亚型以髓源性抑制细胞浸润为主，表现出强烈的免疫抑制状态；而IA亚型则具有丰富的T细胞浸润和高表达免疫检查点分子，对ICIs治疗响应最佳［34］。TME的异质性导致不同患者对ICIs治疗的响应差异显著，如何针对不同TME特征制定胃癌患者个体化治疗策略是未来研究的重要方向。四、结语与展望免疫治疗已成为胃癌治疗体系的重要组成部分，可显著改善晚期及围手术期患者的临床结局。目前，PD-1抑制剂联合化疗被确立为HER-2阴性晚期胃癌的一线标准方案，可明显延长患者OS。在局部进展期胃癌的围手术期治疗中，ICIs治疗亦展现出较高的pCR率和MPR率，尤其对dMMR/MSI-H型患者疗效显著。此外，双特异性抗体、抗体偶联药物（antibody-drug conjugate，ADC）及细胞治疗等新型免疫治疗策略的不断涌现，为胃癌患者提供了更多选择。其中，双特异性抗体可同时识别肿瘤相关抗原（如HER-2、Claudin 18.2）和免疫效应细胞表面分子，将T细胞或自然杀伤细胞精准募集至肿瘤部位并介导特异性细胞毒作用，从而增强抗肿瘤免疫应答。在Ⅲ期COMPASSION-15研究中，与单纯化疗相比，PD-1/CTLA-4双特异性抗体卡度尼利单抗联合化疗在晚期或转移性HER-2阴性胃癌/GEJC患者中显著延长了OS和PFS［8］。此外，EDGE-Gastric研究在HER-2阴性晚期胃癌中，评估了抗TIGIT抗体Domvanalimab联合抗PD-1抗体赛帕利单抗及FOLFOX化疗的疗效，结果显示ORR达59%，中位PFS为12.9个月，OS为26.7个月，其中PD-L1阳性患者获益更为显著［35］。而ADC则通过将高效细胞毒药物与特异性抗体偶联，识别肿瘤特异抗原（如HER-2或Claudin 18.2）实现精准递药和对肿瘤细胞的靶向杀伤。在DESTINY-Gastric系列研究中，代表性药物德曲妥珠单抗（T-DXd）显示出显著疗效［36-38］，并正在DESTINY-Gastric05等研究中与帕博利珠单抗联合评估其免疫协同潜力。尽管如此，胃癌ICIs治疗仍面临诸多科学和临床挑战：原发性与继发性耐药机制尚不明确，尤其在DGC和CIN型患者中响应有限；irAEs需依托多学科团队实施个体化管理策略；TME的高度异质性是导致疗效差异的重要原因。突破这些瓶颈需进一步揭示胃癌免疫生物学的内在机制，开发新靶点药物，并确立更精准预测疗效的生物标志物体系。未来胃癌ICIs治疗的发展方向应包括：①开发新型ICIs治疗药物和联合策略，如靶向CD47-SIRPα轴、双特异性抗体、ADC等；②优化个体化治疗策略，基于分子分型、生物标志物和ctDNA动态监测实现精准医疗；③探索ICIs治疗与其他治疗模式的联合，如靶向治疗、放疗、表观遗传药物等，以逆转免疫抑制微环境；④设计创新的临床试验，采用适应性设计和新终点，加速药物研发和临床应用。多学科协作是胃癌ICIs治疗成功的关键。肿瘤内科、外科、放疗科、病理科、影像科等需要紧密合作，为患者提供全程管理和个体化治疗。随着对胃癌免疫生物学理解的深入和治疗策略的优化，ICIs治疗有望进一步提高胃癌患者的生存率和生活质量，最终实现将胃癌变为可控慢性病的愿景。参考文献（在框内向上滑动手指即可浏览全部参考文献）［1］ Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries[J]. CA Cancer J Clin, 2024, 74(3): 229–263. ［2］中华医学会肿瘤学分会早诊早治学组. 胃癌早诊早治中国专家共识(2023版)[J]. 中华消化外科杂志, 2024, 23(1): 23–36. ［3］ Guan WL, He Y, Xu RH. Gastric cancer treatment: recent progress and future perspectives[J]. J Hematol Oncol, 2023, 16(1): 57. ［4］ Janjigian YY, Shitara K, Moehler M, et al. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): A randomised, open-label, phase 3 trial[J]. Lancet, 2021, 398(10294): 27–40. ［5］ Rha SY, Oh DY, Yañez P, et al. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for HER2-negative advanced gastric cancer (KEYNOTE-859): A multicentre, randomised, double-blind, phase 3 trial[J]. Lancet Oncol, 2023, 24(11): 1181–1195. ［6］ Xu J, Jiang H, Pan Y, et al. 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Applications and challenges of immunotherapy in the management of gastric adenocarcinoma: current status and future perspectives[J]. World J Surg Oncol, 2025, 23(1): 92. ［20］ Shitara K, Van Cutsem E, Bang YJ, et al. Efficacy and safety of pembrolizumab or pembrolizumab plus chemotherapy vs chemotherapy alone for patients with first-line, advanced gastric cancer: the KEYNOTE-062 phase 3 randomized clinical trial[J]. JAMA Oncol, 2020, 6(10): 1571–1580. ［21］ André T, Tougeron D, Piessen G, et al. Neoadjuvant nivolumab plus ipilimumab and adjuvant nivolumab in localized deficient mismatch repair/microsatellite instability-high gastric or esophagogastric junction adenocarcinoma: the GERCOR NEONIPIGA phase Ⅱ study[J]. J Clin Oncol, 2023, 41(2): 255–265. ［22］ Janjigian YY, Kawazoe A, Yañez P, et al. The KEYNOTE-811 trial of dual PD-1 and HER2 blockade in HER2-positive gastric cancer[J]. Nature, 2021, 600(7890): 727–730. ［23］ Kelly RJ, Landon BV, Zaidi AH, et al. 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Adv Sci (Weinh), 2025, 12(25): e2417593. ［35］ Janjigian YY, Oh DY, Pelster M, et al. Domvanalimab and zimberelimab in advanced gastric, gastroesophageal junction or esophageal cancer: A phase 2 trial[J]. Nat Med, 2025, 31(12): 4274-4280. ［36］ Shitara K, Bang Y J, Iwasa S, et al. Trastuzumab deruxtecan in HER2-positive advanced gastric cancer: exploratory biomarker analysis of the randomized, phase 2 DESTINY-Gastric01 trial[J]. Nat Med, 2024, 30(7): 1933–1942. ［37］ Peng Z, Chen P, Lu J, et al. Trastuzumab deruxtecan in patients from China with previously treated human epidermal growth factor receptor 2-positive locally advanced/metastatic gastric or gastroesophageal junction adenocarcinoma (DESTINY-Gastric06): results from a single-arm, multicenter, phase 2 trial[J]. EClinicalMedicine, 2025, 87: 103404. ［38］ Van Cutsem E, di Bartolomeo M, Smyth E, et al. Trastuzumab deruxtecan in patients in the USA and Europe with HER2-positive advanced gastric or gastroesophageal junction cancer with disease progression on or after a trastuzumab-containing regimen (DESTINY-Gastric02): primary and updated analyses from a single-arm, phase 2 study[J]. Lancet Oncol, 2023, 24(7): 744–756. 版权声明本文为《中华普通外科学文献（电子版）》原创文章，版权归中华医学会所有。其他媒体、网站、公众号等如需转载本文，请联系本刊获得授权，并在文题下醒目位置注明“原文刊发于《中华普通外科学文献（电子版）》，卷（期）：起止页码”。谢谢合作！往期回顾栏目特色｜《中华普通外科学文献（电子版）》医学视听投稿指南｜《中华普通外科学文献（电子版）》稿件收录范畴一览内容来源｜《中华普通外科学文献（电子版）》2026年第20卷第3期期刊名称｜中华普通外科学文献（电子版）排版：柏琴初审：丁文珠复审：周奇终审：匡铭

2026-08-12

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癌症治疗后，为什么越来越关注肠道微生态？

癌症治疗后，为什么越来越关注肠道微生态？摘要癌症治疗在挽救生命的同时，也在悄悄破坏患者体内的肠道微生态。近年来，越来越多的研究揭示，肠道菌群不仅影响化疗、放疗的疗效和副作用，更是决定免疫治疗成败的关键因素。2025—2026年多项临床试验证实，菌群移植（FMT）联合免疫检查点抑制剂可使晚期黑色素瘤客观缓解率达到65%—80%，非小细胞肺癌缓解率高达80%。肠道微生态正在从被忽视的"旁观者"转变为癌症治疗中不可忽视的"核心变量"。一、癌症治疗的“隐形代价”：肠道菌群遭破坏化疗、放疗、抗生素——抗癌路上的"三重打击" 癌症是全球重大健康威胁。据国际癌症研究机构（IARC）数据，2022年全球新发癌症病例约2000万例，死亡约970万例。化疗、放疗和免疫治疗是当前抗癌的三大主力手段，但这些治疗在杀伤肿瘤细胞的同时，也对患者肠道微生态造成了深远影响。化疗药物如环磷酰胺、5-氟尿嘧啶等会直接损伤肠黏膜上皮细胞，导致肠道屏障功能受损。研究表明，化疗后患者肠道内Bifidobacterium（双歧杆菌）和Lactobacillus（乳酸杆菌）等有益菌显著减少，而条件致病菌如Enterococcus（肠球菌）和Candida（念珠菌）大量增殖。这种菌群失调不仅引发腹泻、黏膜炎等消化道不良反应，还会导致全身性炎症反应，影响治疗效果。放疗同样会破坏肠道菌群平衡。腹部放疗可引起放射性肠炎，进一步加剧菌群紊乱。而治疗过程中频繁使用的广谱抗生素，更是直接清除了大量肠道共生菌，造成菌群多样性的不可逆下降。图源：Li X, et al. eBioMedicine. 2022;82:104163. Figure 1. (CC BY 4.0)二、肠道菌群：抗癌战场上的“隐形战友” 肠道菌群通过代谢、免疫和信号通路参与抗癌全过程肠道微生物群被称为人体的"第二基因组"，包含约100万亿个微生物细胞，其基因总数是人体基因组的100倍以上。在癌症治疗中，肠道菌群并非旁观者，而是通过多条途径积极参与抗癌过程： ● 免疫调节：肠道菌群代谢产生的短链脂肪酸（SCFAs）可以促进调节性T细胞分化，增强CD8+ T细胞的抗肿瘤活性。Bifidobacterium属细菌能够增强树突状细胞功能，与PD-L1抑制剂产生协同抗肿瘤效应 ● 药物代谢：某些肠道细菌表达的酶可以代谢化疗药物，影响其疗效和毒性。例如，表达胞苷脱氨酶的Gammaproteobacteria可以灭活吉西他滨，导致化疗耐药 ● 肿瘤微环境重塑：菌群代谢产物通过血液循环进入肿瘤微环境，调节肿瘤相关巨噬细胞的极化方向，影响免疫抑制或免疫激活状态三、免疫治疗的“菌群密码”：为什么有人有效，有人无效？肠道菌群多样性决定免疫检查点抑制剂的疗效免疫检查点抑制剂（ICI）是近年来肿瘤治疗最重大的突破之一，包括抗PD-1/PD-L1和抗CTLA-4抗体。然而，仅有约20%—40%的患者对ICI治疗产生持久应答。为什么同样接受免疫治疗，效果却天差地别？ 2015年，Routy等人在《Science》上发表的开创性研究首次揭示：肠道菌群组成是决定ICI疗效的关键因素。研究发现，对抗PD-1治疗有响应的黑色素瘤患者，肠道中Akkermansia muciniphila丰度显著高于无响应者。将响应者的肠道菌群移植给无菌小鼠后，小鼠对PD-1抑制剂的抗肿瘤反应显著增强。此后大量研究进一步证实了这一发现： ● 有利菌群：Ruminococcaceae（瘤胃球菌科）、Akkermansia（阿克曼菌属）、Faecalibacterium prausnitzii（普拉梭菌）和Bifidobacterium（双歧杆菌）的丰度与ICI疗效正相关 ● 不利因素：在ICI治疗前或治疗期间使用广谱抗生素，会导致肠道菌群多样性下降，与原发性耐药和更短的生存期显著相关 ● 生物标志物：研究者已开发出TOPOSCORE等基于菌群特征的生物标志物，用于预测ICI获益和菌群失调程度四、菌群移植：破解免疫治疗耐药的新策略 FMT联合免疫治疗：黑色素瘤缓解率达65%—80% 菌群移植（FMT）作为一种直接的微生态干预手段，正在成为克服免疫治疗耐药的新策略。其核心思路是：将健康供体（通常是免疫治疗响应者）的肠道菌群移植给无响应患者，重建其肠道微生态，从而恢复对免疫治疗的敏感性。 MIMic I期试验（生存分析数据）：加拿大MIMic试验纳入20名晚期黑色素瘤患者，在接受抗PD-1治疗前给予单次口服FMT。结果显示：指标 FMT + 抗PD-1 历史对照（单纯抗PD-1）客观缓解率（ORR）65% 33%—44% 中位无进展生存期29.6个月 6.9—9.4个月中位总生存期52.8个月 32.7—36.9个月 1年生存率95% — 3年生存率53% — FMT-LUMINate II期试验（2026年2月，Nature Medicine）：三项同期发表于《Nature Medicine》的研究进一步验证了FMT联合ICI的疗效： ● 非小细胞肺癌（NSCLC）：20名高PD-L1表达患者接受FMT后联合帕博利珠单抗，客观缓解率达到80%，远超历史对照的39%—46%，且无3级及以上不良事件 ● 黑色素瘤：20名患者接受FMT后联合伊匹木单抗+纳武利尤单抗，客观缓解率为75%，高于历史预期的50%—58% ● 肾细胞癌（RCC）：FMT联合ICI同样显示出令人鼓舞的疗效五、化疗与放疗中的“微生态保卫战” 菌群移植减轻治疗毒性，增强放化疗敏感性除了免疫治疗，肠道菌群在化疗和放疗中的作用同样备受关注。减轻化疗毒性：临床试验（NCT04577729）正在评估FMT能否减少结直肠癌患者化疗引起的腹泻和肠道炎症。动物实验已证实，Lactobacillus rhamnosus（鼠李糖乳酸杆菌）通过激活TLR2-ROS-Nrf2通路增强放射保护，而Bacteroides vulgatus（普通拟杆菌）则促进肿瘤细胞DNA修复，影响放化疗效果。增强放疗敏感性： 2025年发表于《Clinical and Translational Medicine》的综述指出，放疗引起的肠道菌群失调会进一步加剧放射性肠炎。通过益生菌补充或FMT恢复菌群平衡，可以增强抗肿瘤免疫反应、提高肿瘤对放疗的敏感性，最终改善治疗疗效并减轻不良反应。造血干细胞移植（HSCT）：在接受造血干细胞移植的血液肿瘤患者中，肠道菌群多样性较高的患者预后更好，移植物抗宿主病（GVHD）发生率和死亡率均显著降低。这为FMT在HSCT后菌群重建中的应用提供了有力依据。六、从实验室到病床：微生态治疗的未来精准化、标准化、个性化——微生态治疗的三大方向 FMT在癌症治疗中展现出巨大潜力，将其从实验室研究推向常规临床应用，关键在于解决供体选择、制备标准化和疗效预测三大核心问题。安复每天在这些方向上已建立起系统性优势： ● 精准供体匹配：依托16S rRNA测序与临床表型数据，建立供体—患者匹配策略，大幅提升FMT疗效可预期性，避免"盲目移植" ● 标准化制备工艺：首创FMT 3.0技术，实现超洁净菌群制备，统一剂量、给药途径与质控标准，确保批次间稳定性和结果可重复性 ● 生物标志物指导：构建基于菌群特征的疗效预测工具，可在治疗前评估患者获益潜力，辅助动态监测治疗响应 ● 联合治疗策略：在FMT与免疫治疗、化疗、放疗的联合时序设计上积累真实世界经验，为不同癌种制定个性化微生态干预方案随着多项随机II期试验的推进（如加拿大ME.17研究，NCT06623461），微生态治疗正加速从概念走向临床标准，安复每天将持续以真实临床数据推动这一进程。七、安复每天：引领菌群移植临床应用新征程以临床为基石，推动微生态医疗创新安复每天是深圳湾实验室坪山生物医药研发转化中心旗下唯一孵化的微生物医疗技术服务品牌。自创立以来，安复每天始终坚持"真实临床才是产品检验的唯一标准"的核心理念，致力于推动菌群移植技术的临床应用和创新发展。核心优势： ● 领先的临床数据：已与多家三甲医院开展多项临床试验，在精神疾病、肿瘤等领域的临床入组量处于全球领先地位 ● 创新的技术平台：首创FMT 3.0技术，实现超洁净菌群移植，有效率显著提升 ● 严格的质量控制：建立了包括供体追溯、制备记录和冷链运输在内的全程质量监控体系 ● 专业的研发团队：与中科院院士团队、深圳大学等科研机构深度合作，推动技术创新代表性成果： ●全球首次晚期结直肠癌联合PD-1免疫治疗获病理完全缓解：FMT联合化疗及免疫治疗，1例晚期结直肠癌患者实现pCR（切除标本无存活肿瘤细胞），提示FMT可增强抗肿瘤免疫与化疗敏感性 ●联合约翰霍普金斯大学医学院，全球首次揭示"肠-肝轴"肿瘤转移新机制：多组学研究发现菌群代谢产物经门静脉调控肝脏巨噬细胞极化与NK细胞活性，影响结直肠癌肝转移形成 ●联合国家临床中心，全球首次系统性发现FMT辅助抗抑郁获临床积极成果：FMT联合抗抑郁药显著改善HAMD-17评分，缩短起效时间，成果发表于国际权威期刊《CELL》（细胞）旗下重点期刊 ●人工智能算法搭建，全球领先构建可解释微生物组研究工具：整合宏基因组与机器学习，实现菌群标志物识别、疾病风险预测与机制解析，已应用于多种疾病研究在肿瘤微生态治疗领域，安复每天正积极探索菌群移植联合免疫治疗、化疗增敏等创新方向，为癌症患者带来新的治疗希望。未来，安复每天将继续以患者为中心，以临床为导向，推动精准微生态治疗时代的到来。本文仅供科普参考，不构成医疗建议。具体诊疗请咨询专业医生。参考文献 [1] Hadi DK, et al. Improved survival in advanced melanoma patients treated with fecal microbiota transplantation using healthy donor stool in combination with anti-PD1: final results of the MIMic phase 1 trial. J Immunother Cancer. 2025;13:e012659. [2] Duttagupta S, et al. Phase II trial of fecal microbiota transplantation in combination with ipilimumab and nivolumab in patients with advanced cutaneous melanoma (FMT-LUMINate trial). Cancer Res. 2024;84(7_Supplement):CT258. [3] Barragan-Carrillo R, Zengin ZB, Pal SK. Microbiome Modulation for the Treatment of Solid Neoplasms. J Clin Oncol. 2025;43(24):2734-2738. [4] Zhou L, et al. Microbiome-mediated regulation of chemoradiotherapy response. Front Oncol. 2025;15:1659467. [5] Liao L, et al. Focus on gut microbes: new direction in cancer treatment. Front Oncol. 2025;15:1505656. [6] Ma S, et al. Targeting gut microbiota and metabolites in cancer radiotherapy. Clin Transl Med. 2025;15(10):e70481. [7] Ramesh A, et al. Exploring Fecal Microbiota Transplantation: Potential Benefits, Associated Risks, and Challenges in Cancer Treatment. Cancer Rep. 2026;9(1):e70455. [8] Kleinhans M, et al. From fecal microbiota transplants to targeted intervention for improvement of immune checkpoint inhibition therapy. Expert Rev Anticancer Ther. 2026;26(7):809-816. [9] Dixit S, et al. Microbiome dysbiosis and its modulation in cancer development, prevention and therapy. Front Oncol. 2026;16:1852716. [10] Rahman M, et al. Enhancing Immune Response in Immunotherapy-Resistant Melanoma Through Fecal Microbiota Transplantation: A Systematic Review. Biomed Pharmacol J. 2025;18(4):2705-2714. — End — 商务合作请联系：微信1：aFMT-Wong；微信2：anfumeitian 也可长按识别👇🏻 添加安复每天微信扫码添加 Tip 长按识别 👇 全球首例 | 菌群移植方案成功治愈结直肠癌晚期案例解读菌群移植临床应用建议 | 肿瘤化疗修复治疗的指导说明安复每天菌群移植国内领先品牌专注于科研，FMT3.0开创者为医疗机构、健康管理机构提供服务安复每天是深圳湾实验室坪山生物医药研发转化中心（国有实验室）旗下唯一孵化的微生物医疗技术服务品牌和科研服务商，突破行业停留FMT2.0的瓶颈，首创FMT 3.0技术，实现超洁净菌群移植，拥有国际领先技术优势，现已成为政策首推。专利技术和知识产权 100+ 项 FMT和检测次数 100000+ 次我们的优势 ▫️ P2级实验室 ▫️ GMP洁净生产车间 ▫️ 超1000㎡实验室面积 ▫️ 80%科研人员 ▫️ 设备价值超2亿 ▫️ 10+国家级医疗合作 ▫️ 抗抑郁/抗肿瘤 ▫️ 临床入组量全球领先安复每天专注于微生物医疗领域 Microbiota control diseases, we control the microbiota.

2026-08-10

·北京医学感染与传染研究

柳叶刀·胃肠病学与肝病学 11卷 7-9期（2026年8月10日更新）

THE LANCET Gastroenterology & Hepatology. Volume 11Number7 柳叶刀·胃肠病学与肝病学 11卷 7期 https://www.thelancet.com/journals/langas/issue/current Editorial（社论） 1 Rome V: refining the language of gut–brain disorders 罗马Ⅴ：完善肠–脑疾病的术语体系 The Lancet Gastroenterology & Hepatology The Lancet Gastroenterology & Hepatology. Jul 2026, Vol 11(7)：p541 Comment（述评） 2 A changing HIV treatment landscape: what does lenacapavir mean for people living with HBV? HIV治疗格局之变：来那卡帕韦对HBV感染者意味着什么？ Philippa C Matthews,Marion Delphin,Motswedi Anderson,Joanna Redmond,Stuart Flanagan,Maryam Shahmanesh The Lancet Gastroenterology & Hepatology. Jul 2026, Vol 11(7)：p542 3 Alaska Native peoples and colorectal cancer: opportunities for research and prevention 阿拉斯加原住民与结直肠癌：研究与预防的机遇 Diana Redwood,LaRita Laktonen-Ward,Elena Roik The Lancet Gastroenterology & Hepatology. Jul 2026, Vol 11(7)：p544 4 Breaking the cycle: from documenting data scarcity to enabling global IBD research 打破循环：从记录数据匮乏到推动全球IBD研究 Mohammed Nabil Quraishi,Badr Al-Bawardy,Rupa Banerjee,Maiara Brusco De Freitas,David Epstein,Tine Jess The Lancet Gastroenterology & Hepatology. Jul 2026, Vol 11(7)：p546 Correspondence（读者来信） 5 Cyclic exclusive enteral nutrition in paediatric Crohn's disease 儿童克罗恩病的周期性全肠内营养 Aaron S Bancil,Edward M Giles,Jessica Fitzpatrick The Lancet Gastroenterology & Hepatology. Jul 2026, Vol 11(7)：p550 6 Cyclic exclusive enteral nutrition in paediatric Crohn's disease – Authors’ reply 儿童克罗恩病的周期性全肠内营养——作者回复 Bénédicte Pigneur,Frank M Ruemmele The Lancet Gastroenterology & Hepatology. Jul 2026, Vol 11(7)：p550 7 Upfront medical or surgical treatment in Crohn's disease 克罗恩病的初始药物治疗还是手术治疗 Nurulamin M Noor,Phillip R Fleshner,Gil Y Melmed,Corey A Siegel The Lancet Gastroenterology & Hepatology. Jul 2026, Vol 11(7)：p551 8 Upfront medical or surgical treatment in Crohn's disease – Authors’ reply 克罗恩病的初始药物治疗还是手术治疗——作者回复 Lotte Oldenburg,Anouck E G Haanappel,Geert R D’Haens,Willem A Bemelman The Lancet Gastroenterology & Hepatology. Jul 2026, Vol 11(7)：p552 9 Cirrhotic cardiomyopathy and portal hypertension: addressing the full disease spectrum in heart–liver co-management 肝硬化心肌病与门静脉高压：在心–肝协同治疗中关注完整疾病谱 Madeleine Gill,Geoffrey W McCaughan,Anoop N Koshy,John F O’Sullivan,Avik Majumdar The Lancet Gastroenterology & Hepatology. Jul 2026, Vol 11(7)：p553 Corrections（勘误） 10 Correction to Lancet Gastroenterol Hepatol 2026; 11: 355–66 勘误：柳叶刀·胃肠病学与肝病学 2026; 11: 355–66 The Lancet Gastroenterology & Hepatology. Jul 2026, Vol 11(7)：e9 11 Correction to Lancet Gastroenterol Hepatol 2026; 11: 557–69 勘误：柳叶刀·胃肠病学与肝病学 2026; 11: 557–69 The Lancet Gastroenterology & Hepatology. Jul 2026, Vol 11(7)：e9 News（新闻） 12 Digestive Disease Week 2026 2026年消化疾病周 Bethany Gomersall The Lancet Gastroenterology & Hepatology. Jul 2026, Vol 11(7)：p555 In Focus（焦点） Theatre（剧场） 13 Wee, Poo, Snot: harnessing bodily functions to inspire budding scientists 尿液、粪便、鼻涕：利用身体功能激发未来科学家的兴趣 Peter Ranscombe The Lancet Gastroenterology & Hepatology. Jul 2026, Vol 11(7)：p556 Articles（论著） 14 Adjuvant chemoradiotherapy versus completion total mesorectal excision after local excision for early rectal cancer (TESAR): a multicentre, randomised, controlled, phase 3, non-inferiority trial 辅助放化疗与局部切除后完全全直肠系膜切除术治疗早期直肠癌（TESAR）：一项多中心、随机、对照、3期、非劣效性试验 Laura R Moolenaar,Mahsoem Ali,Theo J Aufenacker,Geerard L Beets,Robbert J I Bosker,Tineke E Buffart,Jacobus WA Burger,Evelien Dekker,Quentin Denost,Pascal G Doornebosch,Peter van Duijvendijk,Hans F J Fabry,Elisabeth D Geijsen,Michael F Gerhards,Wilhelmina M U van Grevenstein,Brechtje A Grotenhuis,Christiaan Hoff,Jeroen W A Leijtens,Koen C M J Peeters,Apollo Pronk,George P van der Schelling,Colin Sietses,Anke B Smits,Boudewijn R Toorenvliet,Anthony W H van de Ven,Emiel G G Verdaasdonk,Ronald J C L M Vuylsteke,Henderik L van Westreenen,Johannes H W de Wilt,David D E Zimmerman,Marilyne M Lange,Nicole C T van Grieken,Barbara A J Bastiaansen,Roel Hompes,Corrie A Marijnen,Marcel G W Dijkgraaf,Leon M G Moons,Pieter J Tanis,Chris Cunningham,J B Tuynmanon behalf of the TESAR Study Group The Lancet Gastroenterology & Hepatology. Jul 2026, Vol 11(7)：p557 15 Effect of one or two cycles of dual immunotherapy with nivolumab and ipilimumab in patients with mismatch repair-deficient rectal cancer (RESET-R): interim results from a multicentre, single-arm, phase 2 trial 纳武利尤单抗联合伊匹木单抗双免疫治疗一或两个周期对错配修复缺陷型直肠癌患者的疗效（RESET-R）：一项多中心、单臂、2期试验的中期结果 Line Schmidt Tarpgaard,Laurids Østergaard Poulsen,Ismail Gögenur,Tobias Freyberg Justesen,Søren Rafael Rafaelsen,Nadia Øgaard,Christina Demuth,Claus Lindbjerg Andersen,Lise Ventzel,Pernille Øhlenschläger Larsen,Anne Ramlov,Ken Ljungmann,Michael Bødker Lauritzen,Laura Vittrup Diness,Jakob Lykke,Vinicius Araújo Barbosa de Lima,Søren Kjær,Søren Salomon,Per Vadgaard Andersen,Per Pfeiffer The Lancet Gastroenterology & Hepatology. Jul 2026, Vol 11(7)：p570 16 The small interfering RNA imdusiran as single and multiple doses in healthy, randomised individuals and non-randomised individuals with chronic hepatitis B (AB-729–001): a phase 1a/b trial 小干扰RNA imdusiran（药物名称）在健康随机个体及慢性乙型肝炎非随机个体中单次及多次给药的研究（AB-729–001）：一项1a/b期试验 Man-Fung Yuen,Edward Gane,Jacinta A Holmes,Simone I Strasser,Apinya Leerapun,Wattana Sukeepaisarnjaroen,Pisit Tangkijvanich,Elina Berliba,Alina Jucov,Yoon Jun Kim,Young-Suk Lim,Emily P Thi,Timothy Eley,Kevin R Gray,Elina Medvedeva,Varun Sharma,Christine Espiritu,Sharie C Ganchua,Bhavna S Paratala,Christina Iott,Heather Sevinsky,Tiffany Fortney,Mark Anderson,Gavin A Cloherty,Michael J Sofia,Ganapati Reddy Pamulapati,Amy C H Lee,Gastón Picchio,Karen D Sims The Lancet Gastroenterology & Hepatology. Jul 2026, Vol 11(7)：p579 17 Intestinal ultrasound to detect postoperative recurrence in patients with Crohn's disease: an international, multidisciplinary, RAND/UCLA appropriateness method study 肠道超声检测克罗恩病术后复发：一项国际多学科RAND/UCLA适宜性方法研究 Christopher Ma,Siwar Albashir,Mariangela Allocca,Anthony de Buck van Overstraeten,Paulo G Kotze,Cathy Lu,Christian Maaser,Giovanni Maconi,Remo Panaccione,Miguel Regueiro,Jordi Rimola,Antonino Spinelli,Stuart A Taylor,Rune Wilkens,Willem Bemelman,Noa Krugliak Cleveland,Krisztina B Gecse,Susan Archer,Soushyant Kiarasi,Linda J Cornfield,Kerri L Novak The Lancet Gastroenterology & Hepatology. Jul 2026, Vol 11(7)：p602 Review（综述） 18 The use of pharmacotherapies in non-cirrhotic metabolic dysfunction-associated steatohepatitis: a UK expert consensus 非肝硬化代谢功能障碍相关脂肪性肝炎的药物治疗：英国专家共识 Jeremy F Cobbold,Hamish Miller,Kate Hallsworth,Pinelopi Manousou,Thomas Marjot,Michael E D Allison,Quentin M Anstee,Matthew J Armstrong,Leah Avery,Vian Azzu,Paul N Brennan,Christopher D Byrne,Tessa M Cacciottolo,Lynsey Corless,Daniel Forton,Timothy Hardy,Vanessa Hebditch,Helen Jarvis,Wenhao Li,Dina Mansour,Stuart McPherson,Yensiew Miao,Joanne Morling,Ashis Mukhopadhya,Benjamin Mullish,Richard Parker,Imran Patanwala,Jay Patel,Michael Pavlides,Tina Reinson,Ian A Rowe,Francesca Saffioti,Faisal Shaikh,Ankur Srivastava,Nwe Ni Than,Emmanuel Tsochatzis,Edvard Volcek,Jeremy W Tomlinson,William Alazawi The Lancet Gastroenterology & Hepatology. Jul 2026, Vol 11(7)：p616 19 Management of colorectal cancer in older adults: an expert panel recommendation to guide daily clinical practice 老年结直肠癌的治疗：指导日常临床实践的专家组建议 Gabor Liposits,Thierry André,Thomas Aparicio,Isacco Montroni,Julien Taieb,Claire Gallois,Eric Van Cutsem,Michel Ducreux,Per Pfeiffer,Sara Lonardi,Geerard L Beets,Karin Haustermans,Naureen Starling,Gerald W Prager,Gunnar Folprecht,Demetris Papamichael The Lancet Gastroenterology & Hepatology. Jul 2026, Vol 11(7)：p627 THE LANCET Gastroenterology & Hepatology. Volume 11Number 8 柳叶刀·胃肠病学与肝病学 11卷 8期 https://www.thelancet.com/journals/langas/issue/current Editorial（社论） 1 Drugging the undruggable in pancreatic cancer 攻克胰腺癌中“不可成药”靶点的药物研发 The Lancet Gastroenterology & Hepatology The Lancet Gastroenterology & Hepatology. Aug 2026, Vol 11(8)：p645 Comment（述评） 2 Effect of repeated elastography measurements in LiverScreen 肝脏筛查项目中重复弹性检测的临床价值 Hannes Hagström,Ying Shang The Lancet Gastroenterology & Hepatology. Aug 2026, Vol 11(8)：p646 3 Metabolic syndrome myopathy: defining an emerging clinical entity in patients with MASLD 代谢综合征肌病：代谢相关脂肪性肝病患者一类新兴临床疾病的确立 Melinda Wang,Jennifer C Lai The Lancet Gastroenterology & Hepatology. Aug 2026, Vol 11(8)：p647 4 All in her head: dismantling medical misogyny in disorders of gut–brain interaction 一切皆源于主观臆症：破除肠脑互动疾病诊疗中的医学厌女偏见 Tiffany H Taft,Tina Aswani-Omprakash,Johannah Ruddy The Lancet Gastroenterology & Hepatology. Aug 2026, Vol 11(8)：p650 Correspondence（读者来信） 5 COLOR III: widespread TaTME dissemination demands a LAPCO-equivalent framework COLOR III研究：经肛全直肠系膜切除术广泛推广亟需建立等同腹腔镜结直肠手术协作组的规范体系 Shazad Q Ashraf,Andrew D Beggs The Lancet Gastroenterology & Hepatology. Aug 2026, Vol 11(8)：p653 6 The spectrum of steatotic liver disease in the USA 美国脂肪性肝病疾病谱 Kartik Jaidka,Naveen Bhagat,Arka De,Ajay Duseja The Lancet Gastroenterology & Hepatology. Aug 2026, Vol 11(8)：p653 7 The spectrum of steatotic liver disease in the USA 美国脂肪性肝病疾病谱 Hans Scherübl The Lancet Gastroenterology & Hepatology. Aug 2026, Vol 11(8)：p654 8 The spectrum of steatotic liver disease in the USA – Authors’ reply 《美国脂肪性肝病疾病谱》——作者答复 James M Paik,Zobair M Younossi The Lancet Gastroenterology & Hepatology. Aug 2026, Vol 11(8)：p655 9 Lessons from a ransomware crisis and its effect on adult liver transplant services 勒索软件网络危机及其对成人肝移植诊疗服务的影响与启示 Abdul Rahman Hakeem,Karen Mercer,Bu Hayee,Oliver Long,Abid Suddle,Wayel Jassem,Parthi Srinivasan,Krishna Menon,Anneliese Rigby,Miriam Cortes-Cerisuelo,Varuna Aluvihare The Lancet Gastroenterology & Hepatology. Aug 2026, Vol 11(8)：p655 Corrections（勘误） 10 Correction to Lancet Gastroenterol Hepatol 2025; 10: 998–1012 《柳叶刀-胃肠病学与肝病学》2025年第10卷998–1012页文章勘误 The Lancet Gastroenterology & Hepatology. Aug 2026, Vol 11(8)：e10 11 Correction to Lancet Gastroenterol Hepatol 2026; 11: 546–49 《柳叶刀-胃肠病学与肝病学》2026年第11卷546–549页文章勘误 The Lancet Gastroenterology & Hepatology. Aug 2026, Vol 11(8)：e10 News（新闻资讯） 12 EASL Congress 2026 2026年欧洲肝脏研究协会年会 Rob Brierley The Lancet Gastroenterology & Hepatology. Aug 2026, Vol 11(8)：p658 13 Research in Brief 研究简讯 Holly Baker The Lancet Gastroenterology & Hepatology. Aug 2026, Vol 11(8)：p659 Articles（论著） 14 HLA-DRB1*01:03 in patients with inflammatory bowel disease: a genotype–phenotype association study 炎症性肠病患者HLA-DRB1*01:03基因型：基因型-表型关联研究 Qian Zhang,Eathar Shakweh,Mohmmed Tauseef Sharip,Benjamin Zare,Christopher Roberts,Nicola J Wyatt,Jennifer Clough,Claire Bewshea,Omar El Garwany,Robert Lees,Saima Mukhtar,Hameed Rehman,Hollie Thistle,Robert Mulligan,Melanie Taylor,Parizade Raymode,Benjamin Hamilton,Nurulamin M Noor,Francesco Morda,Madeleine Taylor,Mina Gyanwali,Ogwa Tobi,Stefanos Kateroglou,Sean Von Hagt,UK IBD Genetics Consortium,NIHR IBD BioResource,Shaji Sebastian,Ailsa Hart,Laura Keylock,Laetitia Pele,Charlie W Lees,Tim Raine,Christopher A Lamb,Carl A Anderson,Tariq Ahmad,Holm Uhlig,Miles Parkes,Laura Fachal,Nicholas A Kennedy,James C Lee The Lancet Gastroenterology & Hepatology. Aug 2026, Vol 11(8)：p660 15 Dupilumab versus placebo in adults and adolescents with eosinophilic gastritis (DEGAS): a double-blind, placebo-controlled, phase 2, multicentre, randomised controlled trial 度普利尤单抗对比安慰剂治疗成人及青少年嗜酸性粒细胞性胃炎（DEGAS研究）：一项Ⅱ期、双盲、安慰剂对照、多中心随机对照临床试验 Nirmala P Gonsalves,Evan S Dellon,Kara L Kliewer,Tetsuo Shoda,Regina Yearout,Seema S Aceves,Nicoleta C Arva,John A Besse,Julie M Caldwell,Mirna Chehade,Amaziah Coleman,Margaret H Collins,Sara Anvari,Gary W Falk,Sandeep K Gupta,Girish Hiremath,David A Katzka,Paneez Khoury,John Leung,Calies Menard-Katcher,Paul Menard-Katcher,Kathryn A Peterson,Maria A Pletneva,Amanda K Rudman Spergel,Jonathan M Spergel,Tatyana Vaysman,Joshua B Wechsler,Benjamin L Wright,Guang-Yu Yang,Xue Zhang,Meijian Zhou,Ashish Bansal,Bram P Raphael,Amr Radwan,Jennifer Maloney,Antonio Martin,Yamo Deniz,Glenn T Furuta,Lisa J Martin,Marc E Rothenbergfor The Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR) Investigators The Lancet Gastroenterology & Hepatology. Aug 2026, Vol 11(8)：p672 16 Liver stiffness dynamics in European populations (LiverScreen): a longitudinal, multicentre, prospective, population-based cohort study 欧洲人群肝脏硬度动态变化研究（肝脏筛查项目）：一项基于人群、多中心、前瞻性纵向队列研究 Jesse Pustjens,Katrine Tholstrup Bech,Guillem Pera,Laurens A van Kleef,Helle Lindholm Schnefeld,Robert J de Knegt,Sarwa Darwish Murad,Harry L A Janssen,Peter Andersen,Johanne Kragh Hansen,Llorenç Caballeria,Carla Chacon,Ingrid Arteaga,Pere Toran,Anita Arslanow,Anna Soria,Marta Cervera,Aleksander Krag,Isabel Graupera,Pere Ginès,Willem Pieter Brouwer,Maja Thieleon behalf of the LiverScreen Consortium Investigators The Lancet Gastroenterology & Hepatology. Aug 2026, Vol 11(8)：p689 17 Addition of ipilimumab to atezolizumab plus bevacizumab in advanced hepatocellular carcinoma (PRODIGE 81-FFCD 2101-TRIPLET HCC): phase 2 results from a randomised, multicentre, open-label, phase 2–3 trial 阿替利珠单抗联合贝伐珠单抗基础上加用伊匹木单抗治疗晚期肝细胞癌（PRODIGE 81-FFCD 2101-TRIPLET HCC研究）：一项多中心、开放标签Ⅱ/Ⅲ期随机临床试验Ⅱ期研究结果 Philippe Merle,Jean-Frederic Blanc,Karine Le Malicot,Jean-Marie Peron,Vincent Bourgeois,Mohamed Bouattour,Yann Touchefeu,Carole Vitellius,Faiza Khemissa Akouz,Alexandra Heurgué,Paul Girot,Eric Assenat,Eric Nguyen-Khac,Jean-Pierre Bronowicki,Juliette Viaud,Meher Ben Abdelghani,Sylvain Manfredi,Julien Edeline,Jean-Marc Phelipfor the TRIPLET-HCC study investigators The Lancet Gastroenterology & Hepatology. Aug 2026, Vol 11(8)：p700 Viewpoint（观点） 18 Breaking the therapeutic ceiling in inflammatory bowel disease: myth or reality? 突破炎症性肠病治疗瓶颈：空想还是现实？ Virginia Solitano,Vipul Jairath,Fernando Magro,Alessandro Armuzzi,Laurent Peyrin-Biroulet,Silvio Danese The Lancet Gastroenterology & Hepatology. Aug 2026, Vol 11(8)：p713 19 Balancing benefit and burden: rethinking post-polypectomy colonoscopy surveillance strategies 权衡获益与医疗负担：重新思考息肉切除术后结肠镜随访监测策略 Joep E G IJspeert,Michael Bretthauer,Rodrigo Jover,Evelien Dekkeron behalf of the Dutch colonoscopy surveillance working group The Lancet Gastroenterology & Hepatology. Aug 2026, Vol 11(8)：p720 THE LANCET Gastroenterology & Hepatology. Volume 11Number 9 柳叶刀·胃肠病学与肝病学 11卷 9期 https://www.thelancet.com/journals/langas/issue/current Editorial（社论） 1 A decade in gastroenterology and hepatology 胃肠病学与肝病学十年回顾 The Lancet Gastroenterology & Hepatology The Lancet Gastroenterology & Hepatology. Num 2026, Vol 11(9)：p727 Comment（评述） 2 Low‑dose aspirin: effective cancer chemoprevention in Lynch syndrome 低剂量阿司匹林：林奇综合征有效的癌症化学预防方案 Kevin J Monahan The Lancet Gastroenterology & Hepatology. Num 2026, Vol 11(9)：p728 3 RELIEVE UCCD: one pathway, two diseases, and a glimpse into the future of IBD trial design RELIEVE‑UCCD研究：同一条通路、两类疾病，窥探炎症性肠病临床试验设计的未来方向 Bram Verstockt The Lancet Gastroenterology & Hepatology. Num 2026, Vol 11(9)：p729 4 Combination therapy in metabolic dysfunction‑associated steatohepatitis 代谢功能障碍相关脂肪性肝炎的联合治疗 Oren Shibolet,Helena Katchman The Lancet Gastroenterology & Hepatology. Num 2026, Vol 11(9)：p732 5 The central role of primary care in liver health 基层医疗在肝脏健康管理中的核心作用 Rob Brierley,Hugh Thomas The Lancet Gastroenterology & Hepatology. Num 2026, Vol 11(9)：p733 6 A decade in inflammatory bowel disease: progress, plateaus, and perspectives 炎症性肠病十年发展：进展、瓶颈与展望 Britta Siegmund The Lancet Gastroenterology & Hepatology. Num 2026, Vol 11(9)：p735 7 A decade of transformation in MASLD: from nomenclature to novel therapies 代谢功能障碍相关脂肪性肝病十年变革：从命名更新到新型疗法 Jörn M Schattenberg,Mazen Noureddin The Lancet Gastroenterology & Hepatology. Num 2026, Vol 11(9)：p737 8 Dietary management of gastrointestinal disease: progress over the last decade and opportunities for the next 胃肠道疾病的膳食干预：近十年进展与未来机遇 Kevin Whelan,Heidi M Staudacher The Lancet Gastroenterology & Hepatology. Num 2026, Vol 11(9)：p738 9 The decade that changed hepatocellular carcinoma: shaping a new treatment paradigm 改写肝细胞癌诊疗格局的十年：构建全新治疗模式 Antonio D’Alessio,Antonella Cammarota,Stephen L Chan,Lorenza Rimassa The Lancet Gastroenterology & Hepatology. Num 2026, Vol 11(9)：p741 10 Ten years of advances in disorders of gut–brain interaction 肠‑脑互动相关疾病十年研究进展 Alexander C Ford,Nicholas J Talley The Lancet Gastroenterology & Hepatology. Num 2026, Vol 11(9)：p743 11 Progress and prospects in viral hepatitis elimination 病毒性肝炎消除工作的进展与前景 C Wendy Spearman,Mark W Sonderup The Lancet Gastroenterology & Hepatology. Num 2026, Vol 11(9)：p745 12 A decade of progress in cholestatic liver diseases: navigating a new era 胆汁淤积性肝病十年进展：迈入全新发展阶段 Vincenzo Ronca,Maria Buzias,Ana Lleo The Lancet Gastroenterology & Hepatology. Num 2026, Vol 11(9)：p748 13 Translating the gut microbiome: where are we? 肠道微生物组的临床转化：当下发展现状 Jeroen Raes The Lancet Gastroenterology & Hepatology. Num 2026, Vol 11(9)：p750 14 A decade of artificial intelligence in endoscopy: from proof of concept to clinical reality 人工智能内镜应用十年：从概念验证走向临床落地 Masashi Misawa,Yuichi Mori The Lancet Gastroenterology & Hepatology. Num 2026, Vol 11(9)：p752 15 A decade of diversity, equity, and inclusion in gastroenterology and hepatology: a US perspective 胃肠肝病领域多元、公平与包容建设十年——美国视角 Pascale M White,Nikki Duong,Laura E Targownik,Sophie Balzora The Lancet Gastroenterology & Hepatology. Num 2026, Vol 11(9)：p754 Correspondence（通信） 16 Therapeutic drift or formulation drift: avoiding misconceptions about rifaximin and antimicrobial resistance in cirrhosis 药效偏移还是制剂差异：厘清肝硬化患者利福昔明与抗菌耐药性的认知误区 Carmelo Scarpignato,Manuel Romero‑Gómez The Lancet Gastroenterology & Hepatology. Num 2026, Vol 11(9)：p757 17 Therapeutic drift or formulation drift: avoiding misconceptions about rifaximin and antimicrobial resistance in cirrhosis –Authors' reply 药效偏移还是制剂差异：厘清肝硬化患者利福昔明与抗菌耐药性的认知误区——作者回复 Rajiv Jalan,Vishal C Patel,Saeed Shoaie The Lancet Gastroenterology & Hepatology. Num 2026, Vol 11(9)：p758 18 Ethnicity, diversity, and inclusion in gastroenterology: from representation to system performance 胃肠病学领域种族、多元与包容建设：从人员覆盖到体系效能 Ajay M Verma,Debbie L Shawcross,Neeraj Bhala The Lancet Gastroenterology & Hepatology. Num 2026, Vol 11(9)：p758 Articles（论著） 19 Aspirin for cancer prevention in individuals with Lynch syndrome: first results from the CaPP3 multicentre, randomised, double‑blind, non‑inferiority trial 阿司匹林用于林奇综合征人群癌症预防：CaPP3多中心随机双盲非劣效性试验初步结果 John Burn,Gillian M Borthwick,Faye Elliott,Finlay Macrae,Kai Ren Ong,Alison C Kraus,Nadir Arber,Jukka‑Pekka Mecklin,Angel Alonso,Emma R Woodward,D Gareth Evans,Alex Murray,Katie Snape,Ruth E Cleaver,Adam Shaw,Huw J W Thomas,Ajith V Kumar,Dorothy Halliday,Lucy E Side,Rachel E Harrison,Rosemarie Davidson,Ruth Armstrong,Jackie Cook,Rachel Hart,Patrick J Morrison,Julian G Barwell,Alan Donaldson,Zoe Kemp,Jennie Murray,Zosia Miedzybrodzka,Caroline Pottinger,Jonathan Berg,Richard Gallon,D Timothy Bishopon behalf of the CaPP3 co‑investigators The Lancet Gastroenterology & Hepatology. Num 2026, Vol 11(9)：p760 20 Efficacy and safety of duvakitug in patients with ulcerative colitis (RELIEVE UCCD): a phase 2b, randomised, placebo‑controlled trial Duvakitug治疗溃疡性结肠炎的疗效与安全性（RELIEVE‑UCCD）：2b期随机安慰剂对照试验 Walter Reinisch,David Stepek,Radoslaw Kempinski,Silvio Danese,Bruce E Sands,Bogdan Ratiu‑Duma,Rajendra Singh,Phillip Levine,Hadas Barkay,Nicholas Gross,Ken Abrams,Vipul Jairath The Lancet Gastroenterology & Hepatology. Num 2026, Vol 11(9)：p775 21 Efficacy and safety of duvakitug in patients with Crohn's disease (RELIEVE UCCD): a phase 2b, randomised, placebo‑controlled trial Duvakitug治疗克罗恩病的疗效与安全性（RELIEVE‑UCCD）：2b期随机安慰剂对照试验 Vipul Jairath,Jaroslaw Kierkuś,George Aaron Duvall,Silvio Danese,Bruce E Sands,Bogdan Ratiu‑Duma,Rajendra Singh,Phillip Levine,Hadas Barkay,Nicholas Gross,Ken Abrams,Walter Reinisch The Lancet Gastroenterology & Hepatology. Num 2026, Vol 11(9)：p786 22 Efficacy and safety of zalfermin co‑administered with semaglutide in participants with fibrosis and cirrhosis due to metabolic dysfunction‑associated steatohepatitis: a phase 2, dose‑ranging, double‑blind, randomised controlled trial 扎弗明联合司美格鲁肽治疗代谢相关脂肪性肝炎所致肝纤维化与肝硬化受试者的疗效及安全性：2期剂量探索双盲随机对照试验 Rohit Loomba,Jacob George,Laurent Castera,Sven Francque,Eric Lawitz,Ahsan Shoeb,Jesper Ole Clausen,Birgitte Andersen,Anna Bille Larsen,Lise Lotte Gluud The Lancet Gastroenterology & Hepatology. Num 2026, Vol 11(9)：p797 23 The Rome V criteria for the diagnosis of irritable bowel syndrome in secondary care: a diagnostic accuracy study 二级医疗机构中罗马V标准诊断肠易激综合征的诊断准确度研究 Kyle Staller,Vivek C Goodory,Mais Khasawneh,Christopher J Black,Alexander C Ford The Lancet Gastroenterology & Hepatology. Num 2026, Vol 11(9)：p812 The Lancet Gastroenterology & Hepatology Commission（《柳叶刀‑胃肠病学和肝病学》专题委员会报告） 24 The role of primary care in response to the global liver disease syndemic: a Lancet Gastroenterology & Hepatology Commission 基层医疗应对全球肝病共病流行的作用——《柳叶刀‑胃肠病学和肝病学》专题委员会报告 Helen Jarvis,Paul N Brennan,Teresa Casanovas,Kelly Casler,Monica Desai,Philip H Evans,John F Dillon,Ignazio Grattagliano,Kate Hallsworth,Vanessa Hebditch,Sema Mandal,Alisa E Pedrana,Jen‑Kuei Peng,Andrew D Schreiner,Abdel‑Aziz Shaheen,Maja Thiele,Patricia C Valery,Julia Verne,Shlomo Vinker,David Whiteley,Martin C S Wong,Shira Zelber‑Sagi The Lancet Gastroenterology & Hepatology. Num 2026, Vol 11(9)：p821

临床结果

100 项与伊匹木单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D04603	伊匹木单抗	L01XC11	DB06186

研发状态

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适应症	国家/地区	公司	日期
微卫星高度不稳定性直肠癌	日本	Bristol-Myers Squibb KK	2025-08-25
PD-L1阳性非小细胞肺癌	中国	Bristol-Myers Squibb Pharma EEIG	2025-07-22
转移性肝细胞癌	澳大利亚	Bristol-Myers Squibb Australia Pty Ltd.	2025-06-27
晚期肝细胞癌	欧盟	Bristol Myers Squibb Co.	2025-03-08
晚期肝细胞癌	冰岛	Bristol Myers Squibb Co.	2025-03-08
晚期肝细胞癌	列支敦士登	Bristol Myers Squibb Co.	2025-03-08
晚期肝细胞癌	挪威	Bristol Myers Squibb Co.	2025-03-08
不可切除的肝细胞癌	欧盟	Bristol Myers Squibb Co.	2025-03-08
不可切除的肝细胞癌	冰岛	Bristol Myers Squibb Co.	2025-03-08
不可切除的肝细胞癌	列支敦士登	Bristol Myers Squibb Co.	2025-03-08
不可切除的肝细胞癌	挪威	Bristol Myers Squibb Co.	2025-03-08
错配修复缺陷或微高卫星不稳定性结肠癌	欧盟	Bristol-Myers Squibb Pharma EEIG	2025-01-13
错配修复缺陷或微高卫星不稳定性结肠癌	冰岛	Bristol-Myers Squibb Pharma EEIG	2025-01-13
错配修复缺陷或微高卫星不稳定性结肠癌	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2025-01-13
错配修复缺陷或微高卫星不稳定性结肠癌	挪威	Bristol-Myers Squibb Pharma EEIG	2025-01-13
不能切除的食管鳞状细胞癌	美国	Bristol Myers Squibb Co.	2022-05-27
食管癌	日本	Bristol-Myers Squibb KK	2022-05-26
肝细胞癌	美国	Bristol Myers Squibb Co.	2020-03-10
皮肤黑色素瘤	美国	Bristol Myers Squibb Co.	2018-07-10
结直肠癌	美国	Bristol Myers Squibb Co.	2018-04-16

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适应症	最高研发状态	国家/地区	公司	日期
膀胱癌	临床3期	美国	Ono Pharmaceutical Co., Ltd.	2022-01-30
HER2阴性胃癌	临床3期	日本	Ono Pharmaceutical Co., Ltd.	2021-11-05
HER2阴性胃癌	临床3期	韩国	Ono Pharmaceutical Co., Ltd.	2021-11-05
HER2阴性胃癌	临床3期	中国台湾	Ono Pharmaceutical Co., Ltd.	2021-11-05
胶质母细胞瘤	临床3期	美国	National Cancer Institute	2020-09-01
神经胶质肉瘤	临床3期	美国	National Cancer Institute	2020-09-01
非小细胞肺癌 III期	临床3期	荷兰	Bristol Myers Squibb Co.	2019-12-16
局部晚期非小细胞肺癌	临床3期	美国	Bristol Myers Squibb Co.	2019-10-08
局部晚期非小细胞肺癌	临床3期	中国	Bristol Myers Squibb Co.	2019-10-08
局部晚期非小细胞肺癌	临床3期	日本	Bristol Myers Squibb Co.	2019-10-08

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临床结果

适应症

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05665348 (PRODIGE 81-FFCD 2101-TRIPLET HCC, Pubmed \| Lancet Gastroenterol Hepatol)	临床2/3期	晚期肝细胞癌一线	226	Atezolizumab + Bevacizumab + Ipilimumab	構廠願餘獵願鬱齋壓構(製鏇獵構觸願廠鑰膚糧) = 3% of patients in the atezolizumab plus bevacizumab group experienced acute renal failure 夢壓繭壓襯鹹廠蓋簾憲 (衊廠壓構鑰蓋廠醖窪夢 ) 更多	不佳	2026-08-01
				Atezolizumab + Bevacizumab
ESMO_GI2026 \| ESMO_GCC2026	N/A	PD-L1阳性食管鳞状细胞癌	26	Nivolumab + ipilimumab	鹹選網艱窪齋艱願廠獵(廠衊製淵選構遞憲鏇選) = 餘構繭廠膚簾餘製獵鏇網獵範醖鑰顧艱築觸選 (簾選衊獵衊鏇襯獵製窪 ) 更多	不佳	2026-07-02
NCT04039607 (CheckMate 9DW, ESMO_GI2026 \| ESMO_GCC2026)	临床3期	不可切除的肝细胞癌一线	208	Nivolumab (NIVO) + ipilimumab (IPI)	鬱衊鑰選齋淵積衊鏇遞(積遞膚鑰顧膚範範構願) = 淵糧衊齋獵衊窪簾廠憲鬱鹽鹽積製蓋鏇齋範糧 (遞齋觸顧憲襯夢鑰蓋窪, 4.9 ~ NR) 更多	积极	2026-07-02
				Lenvatinib (LEN) or Sorafenib (SOR)	鬱衊鑰選齋淵積衊鏇遞(夢鹹選衊憲窪遞鬱觸夢) = 遞醖願獵觸顧膚繭繭繭衊餘壓遞廠獵餘艱顧觸 (築積壓選廠簾願齋壓獵, 13.9 ~ 24.7) 更多
NCT03682276 (PRIME-HCC, CTgov)	临床1/2期	肝细胞癌	33	Ipilimumab+Nivolumab	築鑰糧積範鹽壓獵襯鏇 = 鑰鹽繭繭廠選憲蓋鬱窪憲衊憲膚餘繭窪窪醖廠 (鹽繭艱廠構壓製鬱夢觸, 廠顧醖繭廠蓋遞築顧簾 ~ 襯繭蓋積獵網餘鑰範築) 更多	-	2026-06-29
NCT03958383 (CTgov)	临床1/2期	黑色素瘤	8	hu14.18-IL2 fusion protein (Phase IA)	簾鏇鑰齋鑰遞糧構繭餘 = 鹹範憲積鏇淵鹽鏇餘鑰鏇鏇繭膚齋夢艱淵繭簾 (鏇鏇鹽鑰選範襯範廠憲, 製鏇網鏇遞艱鏇襯製餘 ~ 醖糧築淵選膚觸壓觸齋) 更多	-	2026-06-03
				hu14.18-IL2 (Phase IB)	簾鏇鑰齋鑰遞糧構繭餘 = 襯簾範齋淵壓壓膚糧襯鏇鏇繭膚齋夢艱淵繭簾 (鏇鏇鹽鑰選範襯範廠憲, 艱築憲鹽壓憲膚構壓鬱 ~ 製餘鏇積夢鹹膚鏇獵夢) 更多
ASCO2026	N/A	BRAF V600E阳性黑色素瘤二线 BRAF V600-mutant	63	Ipilimumab plus Nivolumab	繭獵築醖憲範觸顧獵蓋(顧網構夢繭選壓願積廠) = 齋選膚壓網夢憲構鑰鹽糧獵衊夢願製衊製醖簾 (廠獵鏇襯衊構觸餘廠獵 ) 更多	不佳	2026-05-29
				Anti-PD-1 monotherapy	繭獵築醖憲範觸顧獵蓋(顧網構夢繭選壓願積廠) = 衊鏇夢膚鏇淵壓齋製繭糧獵衊夢願製衊製醖簾 (廠獵鏇襯衊構觸餘廠獵 ) 更多
NCT05144854 (ATTRACTION-6, ASCO2026)	临床3期	一线 HER2-negative	626	Nivolumab + Ipilimumab + Chemo	選鏇襯築醖簾膚醖憲壓(網窪艱淵繭鹽夢選窪膚) = 鬱憲構鬱糧鹹積遞築顧齋鑰鬱築選願壓艱膚願 (網餘鹽範構糧選顧鹽壓 ) 更多	不佳	2026-05-29
				Chemo	選鏇襯築醖簾膚醖憲壓(網窪艱淵繭鹽夢選窪膚) = 遞選餘醖顧淵廠鹹餘淵齋鑰鬱築選願壓艱膚願 (網餘鹽範構糧選顧鹽壓 ) 更多
NCT06295159 (ASCO2026)	临床2期	黑色素瘤新辅助	20	Ipilimumab-Nivolumab-Relatlimab (INR)	願鬱廠鹽範醖窪淵襯餘(鹽鏇選鏇觸網鬱鑰衊襯) = 餘鬱鹽構獵鏇鏇鏇遞繭壓壓鑰憲範繭積壓築鹹 (築積範衊衊範鹽膚餘襯, 44.40 ~ 85.84) 更多	积极	2026-05-29
NCT06712927 (RELATIVITY-048, ASCO2026)	临床2期	黑色素瘤	60	Nivolumab 480mg + Relatlimab 160mg IV Q4W + Ipilimumab 1mg/kg IV Q8W	鬱製選顧構繭壓製艱醖(範選獵窪蓋鬱網積膚築) = 廠廠網鬱繭齋鹹壓範鹹築衊選繭窪夢襯遞網齋 (蓋鹽夢繭繭糧衊壓網衊 ) 更多	积极	2026-05-29
				Nivolumab 480mg + Relatlimab 160mg IV Q4W + Ipilimumab 1mg/kg IV Q8W	鬱製選顧構繭壓製艱醖(範選獵窪蓋鬱網積膚築) = 餘鹹鑰艱顧膚夢鏇觸鏇築衊選繭窪夢襯遞網齋 (蓋鹽夢繭繭糧衊壓網衊 )
ASCO2026	N/A	-	637	Ipilimumab/nivolumab	糧顧鑰淵簾憲積簾膚廠(鏇觸襯艱齋壓窪憲繭鑰) = 構糧網積觸蓋繭夢製壓簾構廠選餘構淵鬱鬱夢 (網齋築鑰鑰艱製構製餘 ) 更多	不佳	2026-05-29
				immune checkpoint inhibitor + tyrosine kinase inhibitor	糧顧鑰淵簾憲積簾膚廠(鏇觸襯艱齋壓窪憲繭鑰) = 積簾鏇壓製壓築衊顧鏇簾構廠選餘構淵鬱鬱夢 (網齋築鑰鑰艱製構製餘 ) 更多