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

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.

Trial Details

NCT ID

NCT07562659

Phase

PHASE2

Sponsor

Fudan University

Status

RECRUITING

Cancer Type

Colorectal Cancer

Interventions

• Capecitabine

Locations (sample)

• Shanghai, China|31.22222,121.45806

Key Eligibility Criteria

• Participants must meet all of the following criteria:
• Age ≥18 years, regardless of sex;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, with an expected survival of \>3 months;
• Histologically confirmed postoperative pTNM stage high-risk stage II colorectal cancer;

For full eligibility, visit ClinicalTrials.gov.

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