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RECRUITING
NCT07562711
PHASE2

Randomized Study of Plasma ctDNA Methylation to Guide Adjuvant Chemotherapy Decisions in High-Risk T3N0 Colorectal Cancer

Sponsor: Fudan University

View on ClinicalTrials.gov

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

Interventions

DRUG

Capecitabine

capecitabine for 6 months

DRUG

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