A Randomized Controlled Trial of Plasma ctDNA Methylation-Guided Adjuvant Chemotherapy Decision-Making in High-Risk Stage III (T4N+ or T1-3N2) Colorectal Cancer

Sponsor
Fudan University
Study ID
NCT07562490
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Patients with T4N+ or T1-3N2 disease will be randomly assigned to either the control group (FOLFOX/CAPOX for 6 months) or the intervention group (FOLFOX/CAPOX plus bevacizumab for 6 months) to receive adjuvant therapy. Venous blood samples (8-16 mL) will be collected at 1 month, 3 months, and 6 months postoperatively for dynamic monitoring of plasma ctDNA.

Key Dates

First listed
May 1, 2026
Start date
Apr 1, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

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

Arms

  • Active Comparator: doublet chemotherapy group
    Patients with T4N+ or T1-3N2 disease assigned to control group will receive FOLFOX/CAPOX for 6 months
  • Experimental: doublet chemotherapy + BEV group
    Patients with T4N+ or T1-3N2 disease assigned to intervention group will receive FOLFOX/CAPOX plus bevacizumab for 6 months

Primary Outcome Measure

Patient's 2-year Progression-Free Survival [ Time Frame: 2 years ]

Central Contacts

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