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Randomized Study of Plasma ctDNA Methylation to Guide Adjuvant Chemotherapy Decisions in High-Risk T3N0 Colorectal Cancer
Sponsor: Fudan University
Summary
This study will utilize ctDNA methylation detection to evaluate patients with high-risk T3N0 stage II colorectal cancer who are ctDNA-positive one month after surgery. It aims to investigate the impact of different adjuvant chemotherapy regimens on ctDNA clearance rates and their prognostic significance. By using postoperative ctDNA status to identify patients at high risk of recurrence, the study seeks to implement intensified chemotherapy strategies (treatment escalation) at an early stage, thereby improving ctDNA clearance and ultimately enhancing patient outcomes
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
340
Start Date
2024-11-01
Completion Date
2027-12-31
Last Updated
2026-05-01
Healthy Volunteers
No
Conditions
Interventions
Capecitabine
capecitabine for 6 months
FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
FOLFOX/CAPOX for 3 months; if ctDNA remains positive, switch to FOLFIRI.
Locations (1)
Fudan University Shanghai Cancer Center
Shanghai, China