Retrospective Cohort Study
Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Surg. Jun 27, 2025; 17(6): 106361
Published online Jun 27, 2025. doi: 10.4240/wjgs.v17.i6.106361
Efficacy and safety of sintilimab combined with nab-paclitaxel plus S-1 for neoadjuvant treatment of locally advanced gastric cancer
Qiu-Xian Chen, Yong-Bin Zhang, Wei-Ming Zeng, Yi-Chen Cai, Chen-Bin Lv, Ming-Qiao Lian, Rong-Jie Huang, Ming-Jie Lian, Wei-Long Lian, Qian-Hui Xu, Yu-Qin Sun, Li-Sheng Cai
Qiu-Xian Chen, Yong-Bin Zhang, Wei-Ming Zeng, Chen-Bin Lv, Ming-Qiao Lian, Rong-Jie Huang, Ming-Jie Lian, Wei-Long Lian, Qian-Hui Xu, Yu-Qin Sun, Li-Sheng Cai, Department of General Surgery, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou 363000, Fujian Province, China
Yi-Chen Cai, College of Biotechnology and Pharmaceutical Engineering, Nanjing Tech University, Nanjing 211816, Jiangsu Province, China
Co-first authors: Qiu-Xian Chen and Yong-Bin Zhang.
Co-corresponding authors: Yu-Qin Sun and Li-Sheng Cai.
Author contributions: Chen QX, Zhang YB, Sun YQ, and Cai LS designed this research study; Chen QX and Zhang YB contributed equally to this article, they are the co-first authors of this manuscript; Chen QX, Zhang YB, and Zeng WM were responsible for the acquisition, analysis, and interpretation of data; Chen QX, Xu HQ, and Zhang YB were in charge of drafting the manuscript; Lv CB, Lian MQ, Lian MJ, Lian WL, and Huang RJ were responsible for the statistical analysis of the data; Chen QX, Cai YC, and Sun YQ provided administrative support, technical support, or material support; Sun YQ and Cai LS contributed equally to this article, they are the co-corresponding authors of this manuscript; and all authors thoroughly reviewed and endorsed the final manuscript.
Supported by the Wu Jieping Medical Fund, No. 320.6750.2022-09-14; and the Climbing Fund of PhD Workstation, Zhangzhou Affiliated Hospital of Fujian Medical University, No. PDB202412.
Institutional review board statement: This study was approved by the Medical Ethics Committee of Zhangzhou Affiliated Hospital of Fujian Medical University, approval No. 2023KYB373.
Informed consent statement: Informed consent to be included in the study, or the equivalent, was obtained from all patients.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
STROBE statement: The authors have read the STROBE Statement-checklist of items, and the manuscript was prepared and revised according to the STROBE Statement-checklist of items.
Data sharing statement: The datasets used and/or analyzed during the current study are available from the corresponding author on 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: Li-Sheng Cai, Chief Physician, Department of General Surgery, Zhangzhou Affiliated Hospital of Fujian Medical University, No. 59 West Shengli Road, Zhangzhou 363000, Fujian Province, China. wxccls2024@163.com
Received: February 25, 2025
Revised: March 28, 2025
Accepted: May 13, 2025
Published online: June 27, 2025
Processing time: 94 Days and 18 Hours
Abstract
BACKGROUND

Gastric cancer is a leading global cause of cancer mortality, with poor survival in locally advanced stages. While immune checkpoint inhibitors (ICIs) like sintilimab have improved outcomes in advanced disease, their role as neoadjuvant therapy remains understudied. This study investigates sintilimab combined with nab-paclitaxel/S-1 as preoperative treatment for locally advanced gastric cancer (LAGC), addressing an unmet need for effective neoadjuvant strategies.

AIM

To explore the efficacy and safety of combination treatment with sintilimab and nab-paclitaxel plus S-1 as neoadjuvant therapy for LAGC.

METHODS

Clinical data from 82 patients diagnosed with LAGC, who underwent preoperative treatment and surgery between April 2020 and December 2022, were included. Patients were divided into 2 groups according to treatment regimen: ICI (sintilimab + nab-paclitaxel + S-1; and non-ICI (nab-paclitaxel + S-1). Imaging and pathological efficacy, intra- and postoperative conditions, molecular subtypes, short-term survival outcomes, and safety were compared between the 2 groups.

RESULTS

Imaging evaluation of therapeutic efficacy revealed that the inclusion of ICI yielded a significantly higher complete response rate (13.2% vs 0.0%; P = 0.048), and objective response rate (69.8% vs 31.0%, P = 0.001) compared with non-ICI treatment. Pathological evaluation revealed that the ICI group exhibited a significantly higher pathological complete response rate (13.2% vs 0.0%; P = 0.048) and major pathological response rate (35.8% vs 13.8%; P = 0.041) than those in the non-ICI group. The two-year disease-free survival rate in the ICI group was greater than that in the non-ICI group (83.0% vs 55.2%; P = 0.043). The use of ICI did not increase the incidence of adverse reactions (47.2% vs 41.4%; P = 0.614) or perioperative adverse events (18.9% vs 13.8%; P = 0.761).

CONCLUSION

The combination of sintilimab with nab-paclitaxel + S-1 for neoadjuvant treatment of LAGC improved efficacy in patients without increasing adverse drug reactions and perioperative adverse events, suggesting that this treatment regimen is safe and feasible.

Keywords: Gastric cancer; Neoadjuvant therapy; Immune checkpoint inhibitor; Efficacy; Safety

Core Tip: This study investigated sintilimab (an immune checkpoint inhibitor) plus nab-paclitaxel and S-1 as neoadjuvant therapy for locally advanced gastric cancer. The combination significantly improved pathological complete response and major pathological response rates, while also demonstrating superior 2-year disease-free survival compared to chemotherapy alone, without additional safety concerns. These findings support its potential as an effective preoperative treatment strategy for locally advanced gastric cancer.