Preoperative Systemic Therapy for Colorectal Cancer Peritoneal Metastases

Preoperative Systemic Therapy With FOLFOXIRI Plus Bevacizumab Followed by Cytoreductive Surgery Versus Upfront Cytoreductive Surgery for Resectable Colorectal Peritoneal Metastases: A Randomized Phase 2 Trial

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.

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.