Skip to main content

CLINICAL TRIAL article

Front. Immunol.
Sec. Cancer Immunity and Immunotherapy
Volume 15 - 2024 | doi: 10.3389/fimmu.2024.1431957

SOX combined with tislelizumab and low-dose radiation therapy for the neoadjuvant treatment of locally advanced gastric/gastroesophageal junction adenocarcinoma: Study protocol for a prospective, multicenter, single-arm, phase Ib/II clinical trial

Provisionally accepted
Peng-Fei Zhang Peng-Fei Zhang 1Ye Chen Ye Chen 2Wen-Ke Li Wen-Ke Li 1Zhu-Mei Luo Zhu-Mei Luo 3Ji Chen Ji Chen 4Kun Qian Kun Qian 5Xiao-Dong Chen Xiao-Dong Chen 6Mojin Wang Mojin Wang 1Ming Liu Ming Liu 1*
  • 1 West China Hospital, Sichuan University, Chengdu, Sichuan Province, China
  • 2 Department of Abdominal Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, Sichuan Province, China
  • 3 Department of Oncology, Chengdu Third People's Hospital, Chengdu, Sichuan Province, China
  • 4 Chengdu Seventh People's Hospital, Chengdu, Sichuan Province, China
  • 5 Department of General Surgery, First Affiliated Hospital of Chongqing Medical University, Chongqing, China
  • 6 Sichuan Cancer Hospital, Chengdu, Sichuan Province, China

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

    Recently, the clinical benefits of neoadjuvant chemotherapy combined with immunotherapy have been observed in patients with locally advanced gastric or gastroesophageal junction (G/GEJ) cancer; however, the pathological complete response (pCR) and long-term survival rates are still unsatisfactory.The aim of this study is to investigate the efficacy and safety of chemotherapy combined with tislelizumab and low-dose radiation therapy (LDRT) for the neoadjuvant treatment of locally advanced G/GEJ cancer.This is a prospective, multicenter, single-arm, phase Ib/II trial. In the phase Ib study, 5 patients will be enrolled in each treatment group with different radiation doses. In the phase II study, a total of 44 patients will be enrolled. Eligible patients will be registered and receive three cycles of SOX regimenThis is the first study to explore the efficacy and safety of neoadjuvant chemotherapy combined with tislelizumab and LDRT in G/GEJ cancer patients, the results of which may provide novel treatment strategy for patients with locally advanced G/GEJ adenocarcinoma.ClinicalTrials.Gov, identifier NCT06266871.

    Keywords: gastric cancer, Neoadjuvant Therapy, S-1, oxaliplatin, tislelizumab, low-dose radiation therapy

    Received: 13 May 2024; Accepted: 18 Oct 2024.

    Copyright: © 2024 Zhang, Chen, Li, Luo, Chen, Qian, Chen, Wang and Liu. 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: Ming Liu, West China Hospital, Sichuan University, Chengdu, Sichuan Province, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.