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

Sponsor
Fudan University
Study ID
NCT07362836
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • fruquintinib+chemotherapy — DRUG
    fruquintinib combined with chemotherapy (mFOLFOX6 or FOLFIRI regimen)
  • bevacizumab+chemotherapy — DRUG
    bevacizumab combined with chemotherapy (mFOLFOX6 or FOLFIRI regimen)

Study Details

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),

Key Dates

First listed
Jan 23, 2026
Start date
Jan 31, 2026
Status verified
Jan 2026
Primary completion
Dec 30, 2028
Completion
Jan 30, 2030

Study Design

Enrollment
224 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: fruquintinib+chemotherapy
    fruquintinib combined with chemotherapy (mFOLFOX6 or FOLFIRI regimen)
  • Active Comparator: bevacizumab+chemotherapy
    bevacizumab combined with chemotherapy (mFOLFOX6 or FOLFIRI regimen)

Primary Outcome Measure

Progression-Free Survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months ]

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