XELOX Combined With Sintilimab and HBO for Advanced or Metastatic GC/GEJC

Summary

This study investigates the efficacy and safety of XELOX chemotherapy combined with sintilimab and hyperbaric oxygen therapy (HBOT) as a first-line treatment for patients with Advanced or Metastatic gastric and gastroesophageal junction adenocarcinoma. The trial comprises two phases: a phase Ib study to determine the optimal HBOT regimen and assess safety and tolerability, followed by a phase II study to evaluate the overall response rate (ORR). Secondary outcomes include progression-free survival (PFS), disease control rate (DCR), 2-year disease-free survival (DFS), 2-year overall survival (OS), safety, and quality of life. This study aims to provide a novel approach for enhancing therapeutic efficacy and improving patient outcomes by leveraging HBOT to address tumor hypoxia and augment the effects of chemotherapy and immune checkpoint inhibitors.

Timeline

Start

2024-12-31

Primary completion

2026-12-31

Completion

2026-12-31

Publications

• Li W, Zhang P, Cheng M, Wei J, Xu M, Li D, Song S, Liu M, Huang C, Zhu L. XELOX combined with sintilimab and hyperbaric oxygen therapy for advanced or metastatic gastric/gastroesophageal junction adenocarcinoma: study protocol for a prospective, single-arm, phase Ib/II clinical trial. Front Immunol. 2026 Jan 12;16:1672725. doi: 10.3389/fimmu.2025.1672725. eCollection 2025.

Drugs

Indications