NCT05727163

FOLFOX Via HAI Plus Intravenous Irinotecan With or Without Bevacizumab Versus Systemic FOLFOXIRI With or Without Bevacizumab in Initially Unresectable RAS-mutated CRLM Patients

FOLFOX Via Hepatic Artery Infusion Chemotherapy (HAI) Plus Systemic Irinotecan With or Without Bevacizumab Versus Systemic FOLFOXIRI With or Without Bevacizumab in Patients With Initially Unresectable RAS-mutated Colorectal Cancer With Liver Metastases: A Prospective, Randomized, Controlled Clinical Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 194 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This prospective, randomized, controlled clinical study aims to evaluate the objective remission rate of FOLFOX hepatic artery infusion chemotherapy (HAI) in combination with systemic irinotecan with or without bevacizumab versus systemic intravenous FOLFOXIRI with or without bevacizumab in initially unresectable RAS-mutated colorectal cancer patients with liver metastases.

Detailed description

PRIMARY OBJECTIVES: The goal of this prospective, randomized, controlled clinical trial is to evaluate the objective remission rate (ORR) of FOLFOX hepatic artery infusion chemotherapy (HAI) in combination with irinotecan with or without bevacizumab systemic intravenous chemotherapy versus systemic intravenous FOLFOXIRI with or without bevacizumab in initially unresectable RAS-mutated colorectal cancer patients with liver metastases. SECONDARY OBJECTIVES: To assess and compare the depth of response (DpR), R0 surgical resection rate, No evidence of disease (NED) rate, progression-free survival (PFS), overall survival (OS), recurrence-free survival (RFS) in resectable patients and safety (chemotherapy-related adverse events, catheterization-related adverse events, surgical complications, etc.) between the two intervention groups. OUTLINE: Patients in the HAI group receive FOLFOX via hepatic artery infusion chemotherapy plus intravenous irinotecan with or without bevacizumab every 14 days, while patients in the systemic group receive intravenous FOLFOXIRI regimen with or without bevacizumab every 14 days. Patients will receive a maximum of 12 cycles in total (before and after surgery) unless there is disease progression, unacceptable toxicity, or if the patient withdraws from the study.

Conditions

• Colorectal Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Dexamethasone	25mg via HAI (Pre-chemotherapy)
DRUG	Anisodamine	10 mg via HAI (Pre-chemotherapy)
DRUG	Oxaliplatin	85 mg/m2 via HAI over 3 hours
DRUG	Leucovorin	200 mg/m2 via HAI
DRUG	Fluorouracil	400 mg/m2 via HAI and 2.4g/m2 via HAI over 48 hours
DRUG	Irinotecan	150 mg/m2 intravenously
DRUG	Bevacizumab	5 mg/kg intravenously
DRUG	Oxaliplatin	85 mg/m2 intravenously over 3 hours
DRUG	Leucovorin	200 mg/m2 intravenously
DRUG	Fluorouracil	400 mg/m2 intravenously + 2400 mg/m2 continuous intravenous infusion over 46 hours

Timeline

• Start date: 2022-07-29
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2023-02-14
• Last updated: 2025-05-30

Locations

1 site across 1 country: China