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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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;

• Expected survival of \>12 months;

• Ability to understand and willingness to sign a written informed consent form (personally or via a legally authorized representative/guardian), indicating that the subject understands the study objectives and required procedures and agrees to participate.

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Guoxiang Cai
gxcaifuscc@163.com
86-18017312703
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 340
Treatments
Active_comparator: Single-agent chemotherapy group
The control group will receive postoperative capecitabine monotherapy for 6 months.
Experimental: doublet chemotherapy group
The intervention group will receive FOLFOX or CAPOX for 3 months. After 3 months of treatment, ctDNA status will be reassessed. Patients who convert to ctDNA-negative will receive capecitabine monotherapy for an additional 3 months, whereas those who remain ctDNA-positive will switch to FOLFIRI or CAPIRI for a further 3 months.
Related Therapeutic Areas
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov