The Efficacy and Safety of HIPEC Combined With PD-1 and SOX Chemotherapy for the Translational Treatment of GC or EGJC With PM

Summary

Gastric cancer (GC) with peritoneal metastasis has a poor prognosis and short survival. In recent years, heat intraperitoneal perfusion chemotherapy (HIPEC) has gained better efficacy in the treatment of peritoneal metastases of many malignant tumors, including GC with peritoneal metastasis. The use of immune checkpoint inhibitors (ICIs) in the treatment of advanced GC has made significant progress in recent years. And studies showed that patients who were responded to immunotherapy combined with chemotherapy as the first-line treatment were able to achieve significant survival benefit after radical resection. However, whether HIPEC combined with immunotherapy for peritoneal metastatic gastric cancer improves the R0 resection rate and prolongs survival time is currently unclear. Therefore, we conducted this prospective multicenter clinical trial to explore the effective dose and safety of the combination of systemic chemotherapy, HIPEC, anti-PD-1 and anti-HER-2 therapy, which will provide a clinical basis for the treatment of advanced GC.

Timeline

Start

2024-05-31

Primary completion

2026-05-31

Completion

2027-05-31

Publications

• Zhang Y, Li F, Liu H, Li P, Li Q, Wang L, Zhang D, Wu H, Xu H, Yang L, Xu ZK. Efficacy and safety of HIPEC combined with PD-1 and SOX chemotherapy for gastric or oesophagogastric junctional cancer with peritoneal metastasis (HISTORIA): protocol for a prospective, multicentre, single-arm, phase II study. BMJ Open. 2025 Sep 14;15(9):e098326. doi: 10.1136/bmjopen-2024-098326.

Drugs

Indications