drugset / Trial / NCT07362836

Fruquintinib Versus Bevacizumab Plus Chemotherapy in Second-Line RAS-Mutant Metastatic Colorectal Cancer (FRU-RAS)

NCT07362836

Phase 3 Not yet recruiting 224 enrolled Fudan University
RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of fru+chemo as second-line therapy for patients with RAS-Mutant Metastatic Colorectal Cancer, especially when compared with the standard therapy BEV+chemo. The trial aims to provide this kind of patients with a more beneficial therapeutic option. Eligible patients were randomly assigned to the experimental group or the control group at a ratio of 1:1, Experimental group: Patients received fruquintinib combined with chemotherapy (mFOLFOX6 or FOLFIRI regimen), Control group: Patients received bevacizumab combined with chemotherapy (mFOLFOX6 or FOLFIRI regimen),

Timeline

Start
2026-01-31
Primary completion
2028-12-30
Completion
2030-01-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bevacizumab Monoclonal antibody 5 mg/kg Intravenous
Background Fruquintinib Small molecule 4 mg Oral
Background Fruquintinib Small molecule 400 mg/m2 Intravenous
Background Irinotecan Small molecule 180 mg/m2 Intravenous
Background Oxaliplatin Small molecule 85 mg/m2 Intravenous
Background fluorouracil Small molecule 400 mg/m2 Intravenous
Background fluorouracil Small molecule 1200 mg/m2 Intravenous

Indications