Actively Recruiting
A Randomized Controlled Trial of Plasma ctDNA Methylation-Guided Adjuvant Chemotherapy Decision-Making in High-Risk Stage III (T4N+ or T1-3N2) Colorectal Cancer
Led by Fudan University · Updated on 2026-05-01
100
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Patients with T4N+ or T1-3N2 disease will be randomly assigned to either the control group (FOLFOX/CAPOX for 6 months) or the intervention group (FOLFOX/CAPOX plus bevacizumab for 6 months) to receive adjuvant therapy. Venous blood samples (8-16 mL) will be collected at 1 month, 3 months, and 6 months postoperatively for dynamic monitoring of plasma ctDNA.
CONDITIONS
Official Title
A Randomized Controlled Trial of Plasma ctDNA Methylation-Guided Adjuvant Chemotherapy Decision-Making in High-Risk Stage III (T4N+ or T1-3N2) Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 with expected survival over 3 months
- Histologically confirmed high-risk stage II colorectal cancer after surgery
- Positive plasma ctDNA status at 1 month post-surgery
- Expected survival longer than 12 months
- Ability to understand and willing to sign informed consent (self or legal guardian)
You will not qualify if you...
- Received neoadjuvant therapy before surgery
- Blood transfusion during surgery or within 2 weeks before surgery
- Pregnant or breastfeeding women or individuals of reproductive potential not using contraception
- History of other cancers within past 5 years except treated carcinoma in situ of cervix or non-melanoma skin cancer
- Uncontrolled brain tumors, CNS metastases, intracranial hypertension, or neuropsychiatric symptoms
- Severe or uncontrolled comorbidities including unstable cardiac disease, neurological or psychiatric disorders, severe infections, active blood clotting or bleeding disorders, or major organ impairment
- Any other condition deemed unsuitable by the investigator
AI-Screening
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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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