Phase 2 Study of Systemic Chemotherapy, Immune Checkpoint Inhibitors, and HIPEC for Treating Gastric Cancer with Peritoneal Metastasis

What this Trial Is About

Researchers are evaluating a treatment approach for patients with gastric cancer that has spread to the peritoneum, an advanced disease stage with poor prognosis. This phase II clinical trial aims to study the effect of combining hyperthermic intraperitoneal chemotherapy HIPEC with systemic chemotherapy and immune checkpoint inhibitors on the rate of complete tumor removal R0 resection. The study also examines overall survival, progression-free survival, tumor burden, and treatment side effects in these patients. The treatment involves HIPEC using oxaliplatin heated to 43C for 60 minutes following laparoscopic surgery, combined with systemic chemotherapy SOX regimen including oxaliplatin and S-1 and immune checkpoint inhibitor therapy with tislelizumab given every three weeks. Participants will receive this combined regimen to assess its safety and potential to improve outcomes for peritoneal metastasis from gastric cancer. Participants will undergo laparoscopic exploration to confirm eligibility, followed by treatment and regular follow-up for up to three years. Researchers will monitor tumor removal success, survival rates at 1, 2, and 3 years, progression-free survival, and adverse reactions. The study includes detailed assessments of organ function, performance status, and adverse events throughout the treatment and observation period to evaluate safety and effectiveness.

A Clinical Study Evaluating the Efficacy of Systemic Chemotherapy and Immune Checkpoint Inhibitors Combined With Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Gastric Cancer Patients With Peritoneal Metastasis