Randomized Trial of Plasma ctDNA Methylation-Guided Adjuvant Therapy in T4N0 and Low-Risk Stage III Colorectal Cancer
Recruiting now · Phase 2
Conditions studied: ctDNA, Colorectal Cancer, Chemotherapy
In brief
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.
Key facts
- Study ID
- NCT07562503
- Run by
- Fudan University
- People needed
- 340
- Starts
- 2024-11-01
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-05-01
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Receipt of neoadjuvant therapy prior to surgery;
- Blood transfusion during surgery or within 2 weeks prior to surgery;
- Pregnant or breastfeeding women, or individuals of reproductive potential who are not using adequate contraception;
- History of other malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix or non-melanoma skin cancer;
- Uncontrolled primary brain tumors or central nervous system metastases, or presence of significant intracranial hypertension or neuropsychiatric symptoms;
- Presence of severe or uncontrolled comorbidities, including but not limited to:Severe cardiac disease that remains unstable despite treatment, including myocardial infarction, congestive heart failure, unstable angina, symptomatic pericardial effusion, or unstable arrhythmia within 6 months prior to enrollment; Clearly diagnosed neurological or psychiatric disorders, including dementia or seizure disorders;Severe or uncontrolled infections;Active disseminated intravascular coagulation (DIC) or significant bleeding tendency;Significant impairment of major organ function;
- Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in this study.
Where it is running
- Fudan University Shanghai Cancer Center — Shanghai, China (enrolling)
Full record on ClinicalTrials.gov
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