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

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

Trial Details

NCT ID
NCT07562711
Phase
PHASE2
Sponsor
Fudan University
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Capecitabine
  • FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
Locations (sample)
  • Shanghai, China|31.22222,121.45806

Key Eligibility 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;
  • Positive ctDNA status at 1 month after surgery;

For full eligibility, visit ClinicalTrials.gov.

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