RecruitingPhase 1Phase 2NCT06742411

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

A Phase Ib/II Clinical Trial of the XELOX Regimen Combined With Sintilimab and Hyperbaric Oxygen Therapy for the Treatment of Advanced or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma

Sponsor

West China Hospital

Enrollment

57 participants

Start Date

Dec 31, 2024

Study Type

INTERVENTIONAL

Conditions

Gastric (Stomach) Cancer

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of three treatments — chemotherapy (XELOX), an immunotherapy drug (sintilimab), and hyperbaric oxygen therapy (breathing pure oxygen in a pressurized chamber) — for people with advanced or metastatic stomach or gastroesophageal junction cancer that has not been treated before. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed adenocarcinoma of the stomach or where the esophagus meets the stomach - Your cancer has spread (metastatic) and has not been treated with chemotherapy, targeted therapy, or immunotherapy before - You are in reasonably good physical condition (able to carry out light activities) - Your heart, liver, and kidney function is within acceptable ranges **You may NOT be eligible if...** - Your cancer is HER2-positive - You have active, uncontrolled cancer spread to the brain - You had major surgery within the past 4 weeks - You have active autoimmune disease requiring systemic treatment - You have had a stroke, blood clot, or significant bleeding event in the past 6 months - You have HIV, untreated hepatitis B or C - You have severe heart or lung conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGXELOX+Sintilimab+HBOT

Patients will receive the XELOX regimen, consisting of oxaliplatin (130 mg/m² IV on Day 1) and capecitabine (1000 mg/m² orally twice daily for 14 days, repeated every 3 weeks), combined with sintilimab (200 mg IV on Day 1 every 3 weeks) and hyperbaric oxygen therapy (HBOT) administered alongside the XELOX regimen. Treatment will be administered for 4 to 6 cycles. Following the initial treatment phase, patients will be evaluated for response. If disease progression is observed, patients will exit the study and receive subsequent treatments as deemed appropriate. For patients with stable disease or a response to therapy, maintenance treatment with capecitabine and sintilimab will continue until the occurrence of a study endpoint or other specified criteria.