Actively Recruiting
Randomized Study of Plasma ctDNA Methylation to Guide Adjuvant Chemotherapy Decisions in High-Risk T3N0 Colorectal Cancer
Led by Fudan University · Updated on 2026-05-01
340
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Randomized Study of Plasma ctDNA Methylation to Guide Adjuvant Chemotherapy Decisions in High-Risk T3N0 Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- ECOG performance status of 0 to 2 with expected survival over 3 months
- Histologically confirmed postoperative high-risk stage II colorectal cancer
- Positive ctDNA status one month after surgery
- Expected survival greater than 12 months
- Ability and willingness to provide informed consent
You will not qualify if you...
- Received neoadjuvant therapy before surgery
- Blood transfusion during or within 2 weeks before surgery
- Pregnant or breastfeeding, or not using adequate contraception if able to conceive
- History of other cancers within the last 5 years except treated carcinoma in situ of cervix or non-melanoma skin cancer
- Uncontrolled brain tumors, CNS metastases, significant intracranial hypertension, or neuropsychiatric symptoms
- Severe or uncontrolled comorbidities including unstable heart disease within 6 months, neurological or psychiatric disorders, severe infections, active bleeding disorders, or major organ dysfunction
- Any other condition making participation unsuitable as judged by the investigator
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
G
Guoxiang Cai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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