HIPEC-AS in Patients With Peritoneal Metastasis of the Stomach or Esophagogastric Junction

Stomach Neoplasms Clinical Trial

Official title: Prospective Study With HIPEC-AS in Patients With Locally Advanced, Limited or Extensive Peritoneal Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction

Status Not yet recruiting

Clinical Trial Summary

HIPEC-AS01 is an open, prospective, single-center phase II clinical study, which will include "cT4aNxM0, P0 or cTxNxM1, P1" patients with gastric or esophagogastric junction adenocarcinoma, to evaluate the efficacy and safety of systemic chemotherapy with HIPEC combined with AS in the perioperative period. Patients enrolled will be divided into three groups. Among them, group A is the patients with locally resectable GC; group B is patients with peritoneal metastasis stage P1a or P1b, group C is patients with peritoneal metastasis stage P1c. The primary purpose is to evaluate the 3-year overall survival rate.

Clinical Trial Description

HIPEC-AS01 is an open, prospective, single-center phase II clinical study, which will include Patients With cT4aNxM0, P0, or cTxNxM1*, P1 Adenocarcinoma of the Stomach or Esophagogastric Junction, to evaluate the efficacy and safety of systemic chemotherapy with HIPEC combined with AS in the perioperative period.

Patients enrolled will be divided into three groups. Among them, group A is the patients with locally resectable GC; group B is patients with peritoneal metastasis stage P1a or P1b, group C is patients with peritoneal metastasis stage P1c.

Intervention:

Group A: 1 cycle HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy (AS plan, Q21d × 3), surgery+HIPEC, sequential 3 cycles of chemotherapy ( AS plan, Q21d × 3).

Group B: 1 cycle HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy (AS plan, Q21d × 3), surgery+HIPEC, sequential 3 cycles of chemotherapy ( AS plan, Q21d × 3).

Group C: 1 cycle HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy (AS plan, Q21d × 3), HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy ( AS plan, Q21d × 3).

In this study, the patient's overall survival was the main evaluation index. It is estimated that the case recruitment will be completed in 2 years, and the follow-up time will be 3 years. The total sample size is approximately 157 cases. ;

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Peritoneal Metastases
• Stomach Neoplasms

• NCT number: NCT05095467
• Study type: Interventional
• Source: Shanghai Zhongshan Hospital
• Contact: Xuefei Wang, MD
• Phone: +86 13917270428
• Email: wang.xuefei@zs-hospital.sh.cn
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 2021
• Completion date: October 2026