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.

ABSTRACT:

Background

Gastric and gastroesophageal junction cancer (GC/GEJC) is the fifth most common and deadliest cancers worldwide, with five-year survival rates ranging from 20-40% due to late-stage diagnosis. First-line treatment for HER2-negative advanced or metastatic GC/GEJC involves chemotherapy combined with PD-1 inhibitors, achieving an objective response rate (ORR) of approximately 60%. However, primary and acquired resistance limits effectiveness, highlighting the need for novel strategies. Tumor hypoxia reduces the efficacy of immune checkpoint inhibitors (ICIs). Hyperbaric oxygen therapy (HBOT) may alleviate hypoxia, enhance drug delivery, and improve immune cell infiltration, potentially increasing the antitumor effects of ICIs.

Methods

This prospective, single-center,

SUBMITTER: Li W 

PROVIDER: S-EPMC12833279 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature