Efficacy and safety of nivolumab plus chemotherapy in patients with advanced gastric cancer with massive ascites

doi:10.4251/wjgo.v18.i1.112944

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World Journal of Gastrointestinal Oncology

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World J Gastrointest Oncol. Jan 15, 2026; 18(1): 112944
Published online Jan 15, 2026. doi: 10.4251/wjgo.v18.i1.112944

Efficacy and safety of nivolumab plus chemotherapy in patients with advanced gastric cancer with massive ascites

Toshihiko Matsumoto, Soma Sugimoto, Reo Omori, Chinatsu Makiyama, Akio Nakasya, Hiroki Nagai, Hisateru Yasui, Reiji Higashi, Akitoshi Sasamoto, Hironaga Satake

Toshihiko Matsumoto, Chinatsu Makiyama, Department of Medical Oncology, Ichinomiyanishi Hospital, Ichinomiya 4940001, Aichi, Japan

Toshihiko Matsumoto, Soma Sugimoto, Reo Omori, Akio Nakasya, Hiroki Nagai, Hisateru Yasui, Hironaga Satake, Department of Medical Oncology, Kobe City Medical Center General Hospital, Kobe 650-0047, Hyōgo, Japan

Reiji Higashi, Department of Gastroenterology, Ichinoimiya Nishi Hospital, Ichinomiya 4940001, Aichi, Japan

Akitoshi Sasamoto, Department of Surgery, Ichinoimiya Nishi Hospital, Ichinomiya 4940001, Aichi, Japan

Hironaga Satake, Department of Medical Oncology, Kochi Medical School, Nankoku 783-8505, Kochi, Japan

Author contributions: Matsumoto T, Omori R, and Nakasya A were involved in data acquisition; Matsumoto T drafted the original manuscript. All authors have reviewed and approved the final version of the manuscript before submission. All authors contributed to the conception and design of this study.

Institutional review board statement: This study was approved by the Institutional Review Board of Kobe City Medical Center General Hospital (No. zn250106).

Informed consent statement: The requirement for informed consent was waived because of the retrospective nature of the study and the opportunity to opt out.

Conflict-of-interest statement: Toshihiko Matsumoto received research funding from Ono Pharmaceutical Co., Ltd. and Sanofi Co., Ltd.; honoraria from Bayer Co., Ltd., Bristol-Myers Squibb Co., Ltd., Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Eli Lilly Japan Co., Ltd., Merck Bio Pharma Co., Ltd., MSD Co., Ltd., Ono Pharmaceutical Co., Ltd., Sanofi Co., Ltd., Taiho Pharmaceutical Co., Ltd., Takeda Co., Ltd., Teijin Pharmaceutical Co., Ltd., and Yakult Honsya. Hironaga Satake has received lecture fees from Chugai, Takeda, and Merck Biopharma. The other authors declare no conflicts of interest.

Data sharing statement: The datasets generated and/or analysed in the present study are available from the corresponding author upon reasonable request.

Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/

Corresponding author: Toshihiko Matsumoto, MD, PhD, Associate Chief Physician, Department of Medical Oncology, Ichinomiyanishi Hospital, 1 Kaimei Aza Hira, Ichinomiya 4940001, Aichi, Japan. makoharutaro2015@gmail.com

Received: August 18, 2025
Revised: September 14, 2025
Accepted: November 19, 2025
Published online: January 15, 2026
Processing time: 147 Days and 14.7 Hours

Abstract

BACKGROUND

Chemotherapy with an immune checkpoint inhibitor is one of the standard regimens for treating advanced gastric cancer (AGC). Ascites and peritoneal dissemination are common complications and poor prognostic factors of AGC; however, reports regarding its efficacy and safety in patients with AGC and massive ascites are limited.

AIM

To evaluate the safety and efficacy of nivolumab combined with chemotherapy in patients with AGC and ascites.

METHODS

We retrospectively collected clinical data from 124 patients with AGC who received chemotherapy plus nivolumab as first-line treatment from July 2017 to December 2024. Based on computed tomography scans, massive or moderate ascites were classified as high ascites burden (HAB), whereas mild or no ascites were classified as low ascites burden.

RESULTS

Ascites was detected in 47 patients (38%); 26 (21%) were classified into the HAB group. Patients in the HAB group exhibited a significantly poorer performance status, a higher prevalence of diffuse-type histology, and lower programmed cell death ligand 1 (PD-L1) expression. Combination therapy with FOLFOX and neutropenia was significantly more common in the HAB group. Progression-free survival (PFS) (4.4 months vs 9.3 months, P = 0.0012) and overall survival (OS) (7.3 months vs 21.2 months, P < 0.0001) were significantly poorer in the HAB group. However, an improvement in ascites was observed in 61.5% of patients in the HAB group. PD-L1 expression did not correlate with either PFS or OS in the HAB group.

CONCLUSION

Nivolumab plus chemotherapy demonstrated modest efficacy and acceptable toxicity in patients with AGC and HAB.

Keywords: Gastric cancer; Ascites; Nivolumab; Chemotherapy plus nivolumab; Immune checkpoint inhibitor

Core Tip: The combination of chemotherapy and immune checkpoint inhibitors has become standard therapy for advanced gastric cancer (AGC). However, data on efficacy in patients with AGC and high ascites burden (HAB) remain limited. Chemotherapy combined with nivolumab has demonstrated modest efficacy in AGC patients with HAB (progression-free survival: 4.4 months; overall survival: 7.3 months). Chemotherapy with nivolumab improved ascites in 56% of patients. Furthermore, these results showed no correlation with programmed cell death ligand 1 (PD-L1) expression. These results suggest that nivolumab chemotherapy could be a therapeutic option for patients with AGC and HAB, regardless of PD-L1 expression.