Actively Recruiting
Randomized Trial of Plasma ctDNA Methylation-Guided Adjuvant Therapy in T4N0 and Low-Risk Stage III 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
The patient (T4N0 or low-risk stage III) will be randomly assigned to either the control group (FOLFOX/CAPOX for 3 months) or the intervention group (FOLFOX/CAPOX for 6 months or FOLFOX/CAPOX for 3 months followed by FOLFIRI/CAPIRI for 3 months) to receive adjuvant therapy. Venous blood samples (8-16 mL) will be collected at 1 month, 3 months, and 6 months after surgery for dynamic monitoring of plasma ctDNA.
CONDITIONS
Official Title
Randomized Trial of Plasma ctDNA Methylation-Guided Adjuvant Therapy in T4N0 and Low-Risk Stage III Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any sex
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 with expected survival over 3 months
- Histologically confirmed postoperative pTNM stage high-risk stage II colorectal cancer
- Positive plasma ctDNA status at 1 month after surgery
- Expected survival longer than 12 months
- Ability to understand and willing to sign informed consent personally or via authorized representative
You will not qualify if you...
- Received neoadjuvant therapy before surgery
- Blood transfusion during surgery or within 2 weeks before surgery
- Pregnant or breastfeeding, or individuals of reproductive potential not using adequate contraception
- History of other cancers within past 5 years except treated cervical carcinoma in situ or non-melanoma skin cancer
- Uncontrolled brain tumors, central nervous system metastases, significant intracranial hypertension, or neuropsychiatric symptoms
- Severe or uncontrolled comorbidities including unstable cardiac disease, neurological or psychiatric disorders, severe infections, active disseminated intravascular coagulation, significant bleeding tendency, or major organ impairment
- Any other condition making the patient unsuitable for the study as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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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