Trifluridine/Tipiracil Plus Fruquintinib vs. Trifluridine/Tipiracil Plus Bevacizumab in Refractory Metastatic Colorectal Cancer: A Randomized, Controlled, Open-Label, Non-Inferiority Trial

Sponsor
Sun Yat-sen University
Study ID
NCT07261709
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Refractory Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • Trifluridine/tipiracil plus fruquintinib — DRUG
    Trifluridine/tipiracil 35 mg/m² orally twice daily on days 1-5 and 8-12, repeated every 4 weeks, plus fruquintinib 4 mg orally once daily for 3 weeks followed by 1 week off, repeated every 4 weeks.
  • trifluridine/tipiracil plus bevacizumab — DRUG
    Trifluridine/tipiracil 35 mg/m² orally twice daily on days 1-5 and 8-12, repeated every 4 weeks, plus bevacizumab 5 mg/kg intravenously on day 1 every 2 weeks.

Study Details

This study is an investigator-initiated, prospective, multicenter, randomized, controlled, open-label, non-inferiority trial designed to evaluate the efficacy and safety of trifluridine/tipiracil plus fruquintinib versus trifluridine/tipiracil plus bevacizumab in the treatment of refractory metastatic colorectal cancer.

Key Dates

First listed
Dec 3, 2025
Start date
Dec 1, 2025
Status verified
Oct 2025
Primary completion
Oct 30, 2027
Completion
Mar 30, 2028

Study Design

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

Arms

  • Experimental: Trifluridine/tipiracil plus fruquintinib
  • Active Comparator: Trifluridine/tipiracil plus bevacizumab

Primary Outcome Measure

PFS [ Time Frame: Time from the date of randomization to the first occurrence of disease progression (as assessed by the investigator according to RECIST v1.1) or death, whichever occurs first,up to 2 years ]

Central Contacts

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