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CASE REPORT article

Front. Immunol.

Sec. Cancer Immunity and Immunotherapy

Volume 16 - 2025 | doi: 10.3389/fimmu.2025.1663107

This article is part of the Research TopicBreakthroughs in Immune Checkpoint Therapy: Overcoming Resistance with Novel TechniquesView all 8 articles

Nivolumab in Gastric Cancer with Liver metastasis Complicated by Immune-Mediated Hepatitis: A Case Report and FAERS Database Analysis

Provisionally accepted
Yong-Li  ZhangYong-Li ZhangJia-Lan  ZhaoJia-Lan ZhaoKe-Jun  QuKe-Jun QuZonglin  JiaoZonglin JiaoYan-Ru  ChenYan-Ru ChenJia  ZhouJia ZhouJiang-Lin  LiJiang-Lin LiJunwei  LiJunwei Li*
  • shenzhen people'hospital, Shenzhen, China

The final, formatted version of the article will be published soon.

Nivolumab is a monoclonal antibody that targets the PD-1 pathway, significantly transforming cancer immunotherapy. However, its use is associated with immune-related adverse events (irAEs), including immune-mediated hepatitis (IMH), which can be severe or even life-threatening. We present a case of an 81-year-old male with gastric cancer and liver metastasis, who demonstrated significant anti-tumor efficacy following nivolumab monotherapy. The patient developed grade 3 IMH during treatment, but after discontinuing the medication and receiving timely treatment, his symptoms improved, and liver biochemical markers declined. Additionally, using the FDA Adverse Event Reporting System (FAERS) database, we analyzed the incidence of hepatitis adverse events caused by different immune checkpoint inhibitors (ICIs) in various age groups of patients to better understand the safety of these drugs in different patient populations.

Keywords: Nivolumab, Immune checkpoint inhibitor, Immune-mediated hepatitis, Immunotherapy, adverse events

Received: 10 Jul 2025; Accepted: 09 Oct 2025.

Copyright: © 2025 Zhang, Zhao, Qu, Jiao, Chen, Zhou, Li and Li. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Junwei Li, lijunwei@stu.hnucm.edu.cn

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