Second-line Standard Treatment Sequential TAS-102 and Bevacizumab Combined With Local Treatment in Advanced Colorectal Cancer

Sponsor
Fudan University
Study ID
NCT06856187
Phase
PHASE2
Status
Recruiting
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Conditions

  • Metastatic Colorectal Cancer (CRC)

Eligibility Criteria

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

Interventions

  • TAS-102+bevacizumab+local treatment — DRUG
    patients achieve disease control after second-line induction therapy with standard therapy(FOLFOX/FOLFIRI/XELOX/ mXELIRI＋bevacizumab/cetuximab), then achieve TAS-102+bevacizumab+local treatment
  • Standard chemotherapy — DRUG
    Standard therapy：FOLFOX/FOLFIRI/XELOX/ mXELIRI±bevacizumab/cetuximab

Study Details

This study is a randomized, controlled, open-label, phase II clinical study. This study is designed to evaluate the efficacy and safety of second-line standard treatment sequential TAS-102 and bevacizumab combined with local treatment versus continuous treatment of standard second-line therapy in advanced colorectal cancer.

Key Dates

First listed
Mar 4, 2025
Start date
Feb 28, 2025
Status verified
Aug 2025
Primary completion
Jun 30, 2026
Completion
Apr 30, 2027

Study Design

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

Arms

  • Experimental: Second-line standard therapy sequential TAS-102 and bevacizumab group
    Second-line induce therapy followed by TAS-102+bevacizumab maintainance therapy combined with local treatment
  • Active Comparator: Continuous therapy of Standard Treatment Group
    Continuous therapy of standard treatment regimen

Primary Outcome Measure

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

Central Contacts

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