TAS-102 Combined With Bevacizumab for Second-line Maintenance Treatment of Advanced Colorectal Cancer

Sponsor
Henan Cancer Hospital
Study ID
NCT06293014
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • TAS-102+bevacizumab — DRUG
    TAS-102 35mg/m2, PO, D1-5, repeated every 14 days; Bevacizumab 5mg/kg, IV, D1, repeated every 14 days; Q4w.
  • Standard chemotherapy+bevacizumab — DRUG
    Standard chemotherapy (chemotherapy regimen based on investigator's choice, including FOLFIRI, FOLFOX, or CAPEOX); Bevacizumab

Study Details

This study is a randomized, controlled, open-label, multicentre clinical study. This study is designed to evaluate the efficacy and safety of TAS-102 combined with bevacizumab as second-line maintenance therapy versus standard chemotherapy combined with bevacizumab as second-line continuous therapy in advanced colorectal cancer after second-line induction therapy.

Key Dates

First listed
Mar 5, 2024
Start date
Feb 23, 2024
Status verified
Feb 2024
Primary completion
Oct 15, 2025
Completion
Nov 28, 2026

Study Design

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

Arms

  • Experimental: second-line maintenance treatment group
    TAS-102 combined with bevacizumab
  • Active Comparator: second-line continuous treatment group
    Standard chemotherapy (FOLFOX，FOLFIRI or CAPEOX) combined with bevacizumab

Primary Outcome Measure

Time to treatment failure (TTF) [ Time Frame: up to approximately 2 years. ]

Central Contacts

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