Low-dose Trifluridine/Tipiracil With Bevacizumab in mCRC

Sponsor
Ruijin Hospital
Study ID
NCT07085169
Phase
PHASE2
Status
Recruiting
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Conditions

  • Bevacizumab
  • Colo-rectal Cancer
  • TAS 102
  • Third-line and Beyond Therapy

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trifluridine/tipiracil (TAS-102) plus bevacizumab — DRUG
    Trifluridine/tipiracil will be given at a 17.5 mg/m2 dose orally twice daily in a 14-day cycle consisting of 10 treatment days/4 rest days. Bevacizumab will be given at a 5mg/kg dose intravenously once at day 1 in a 14-day cycle. This is a single-arm study with all patients receiving these two drugs.

Study Details

This is a phase II, single-center, prospective trial aimed to investigate the efficacy and safety of a modified regimen of trifluridine/tipiracil plus bevacizumab in refractory metastatic colorectal cancer. Patients will be treated with trifluridine/tipiracil (17.5 mg/m2 dose orally twice daily, d1-10, every 14-days) plus bevacizumab (5mg/kg dose intravenously once at day 1, every 14-days). The study treatment will be administered until progression of disease, intolerable toxicity or withdraw of consent.

Key Dates

First listed
Jul 25, 2025
Start date
Aug 1, 2025
Status verified
Jul 2025
Primary completion
Aug 1, 2027
Completion
Aug 1, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    Trifluridine/tipiracil 17.5 mg/m2 bid. po. d1-10, q2w Bevacizumab 5mg/kg ivgtt. d1 q2w

Primary Outcome Measure

6-month progression-free survival rate [ Time Frame: 6 months ]

Central Contacts

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