Preoperative Systemic Therapy for Colorectal Cancer Peritoneal Metastases

• Status: Not yet recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, parallel-group, phase 2 randomized trial which randomizes patients with isolated resectable colorectal cancer peritoneal metastases to receive preoperative systematic therapy followed by CRS+HIPEC and postoperative chemotherapy or upfront CRS+HIPEC followed by postoperative chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University

Criteria

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;

• Historically and radiologically confirmed colorectal cancer peritoneal metastasis except for appendical origin;

• Tolerable to scheduled chemotherapy;

• No evidence of extraperitoneal metastases at enrollment;

• Resectable disease determined by radiological and laparoscopy/laparotomy;

• No systematic therapy within 6 months before enrollment;

• Tolerable to cytoreductive surgery.

Exclusion Criteria:

• Without adequate organ function (e.g. :neutrophil countt≤1.5×10^9/L, or platelets≤75×10^12/L，or hemoglobin<90g/L, or aminotransferase、aspartate aminotransferaseAST<2.5ULN, or total bilirubin<1.5ULN, or creatinine<1.5ULN;

• Emergency surgery;

• Recent thromboembolic event or cerebrovascular disease (12 months before enrollment);

• Pregnancy or lactation

• Comorbid with severe physical or mental disease.