NCT07562490 A Randomized Controlled Trial of Plasma ctDNA Methylation-Guided Adjuvant Chemotherapy Decision-Making in High-Risk Stage III (T4N+ or T1-3N2) Colorectal Cancer
| NCT ID | NCT07562490 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fudan University |
| Condition | ctDNA |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2025-04-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 years, regardless of sex; 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, with an expected survival of \>3 months; 3. Histologically confirmed postoperative pTNM stage high-risk stage II colorectal cancer; 4. Positive ctDNA status at 1 month after surgery; 5. Expected survival of \>12 months; 6. 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. Exclusion Criteria: 1. Receipt of neoadjuvant therapy prior to surgery; 2. Blood transfusion during surgery or within 2 weeks prior to surgery; 3. Pregnant or breastfeeding women, or individuals of reproductive potential who are not using adequate contraception; 4. History of other malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix or non-melanoma skin cancer; 5. Uncontrolled primary brain tumors or central nervous system metastases, or presence of significant intracranial hypertension or neuropsychiatric symptoms; 6. 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; 7. Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in this study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07562490 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying ctDNA. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07562490 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07562490 currently recruiting?
Yes, NCT07562490 is actively recruiting participants. Contact the research team at gxcaifuscc@163.com for enrollment information.
Where is the NCT07562490 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07562490 clinical trial?
NCT07562490 is sponsored by Fudan University. The trial plans to enroll 100 participants.