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RECRUITING
NCT07562659
PHASE2

Randomized Controlled Study of Plasma ctDNA Methylation-Guided Adjuvant Chemotherapy in Stage I/Low-Risk Stage II Colorectal Cancer

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

This study will utilize ctDNA methylation detection to evaluate patients with stage I or low-risk 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.

Official title: A Randomized Controlled Trial of Plasma ctDNA Methylation-Guided Adjuvant Chemotherapy Decisions in Postoperative Stage I or Low-Risk Stage II Colorectal Cancer Patients

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2024-11-01

Completion Date

2027-12-31

Last Updated

2026-05-01

Healthy Volunteers

No

Interventions

DRUG

Capecitabine

Patients with stage I colorectal cancer (CRC) will receive capecitabine monotherapy for 6 months. For patients with stage II CRC, adjuvant treatment will consist of either capecitabine monotherapy for 6 months or FOLFOX/CAPOX for an initial 3 months. After 3 months of treatment, ctDNA status will be reassessed: patients who convert to ctDNA-negative will continue capecitabine monotherapy for an additional 3 months, whereas those who remain ctDNA-positive will switch to FOLFIRI/CAPEIRI for a further 3 months. In addition, venous blood samples (8-16 mL) will be collected at 3 and 6 months postoperatively for dynamic monitoring of plasma ctDNA.

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, China