drugset
drugset / Trial / 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

NCT05727163 ↗

Phase 2 Recruiting 194 enrolled Sun Yat-sen University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2022-07-29
Primary completion
2026-12-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Leucovorin Small molecule 200 mg/m2 Other
Comparator Oxaliplatin Small molecule 85 mg/m2 Other
Comparator fluorouracil Small molecule 400 mg/m2 Other
Comparator fluorouracil Small molecule 2400 mg/m2 Other
Background Anisodamine Traditional medicine (herbal / TCM) 10 mg Other
Background Bevacizumab Monoclonal antibody 5 mg/kg Intravenous
Background Dexamethasone Small molecule 25 mg Other
Background Irinotecan Small molecule 130 mg/m2 Intravenous
Background Irinotecan Small molecule 150 mg/m2 Intravenous

Indications

colorectal cancer