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RECRUITING
NCT07562503
PHASE2

Randomized Trial of Plasma ctDNA Methylation-Guided Adjuvant Therapy in T4N0 and Low-Risk Stage III Colorectal Cancer

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

The patient (T4N0 or low-risk stage III) will be randomly assigned to either the control group (FOLFOX/CAPOX for 3 months) or the intervention group (FOLFOX/CAPOX for 6 months or FOLFOX/CAPOX for 3 months followed by FOLFIRI/CAPIRI for 3 months) to receive adjuvant therapy. Venous blood samples (8-16 mL) will be collected at 1 month, 3 months, and 6 months after surgery for dynamic monitoring of plasma ctDNA.

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

CAPEOX regimen

CAPEOX regimen for 3 months

DRUG

CAPEOX regimen

6 months or FOLFOX/CAPOX for 3 months followed by FOLFIRI/CAPIRI for 3 months

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, China