Using ctDNA methylation to monitor treatment for metastatic colorectal cancer
Official title: ctDNA Methylation for Efficacy Assessment and Prognostic Prediction in Advanced Colorectal Cancer Treated With Radiotherapy Combined With or Without PD-1 Inhibitor: A Prospective Cohort Study (PROMET)
Run by Fudan University · NCT07283575 · Data updated 2026-11-12
We will test whether measuring ctDNA methylation in blood can track treatment response and predict relapse for adults with recurrent or metastatic colorectal cancer receiving radiotherapy plus standard chemotherapy, with or without PD‑1 immunotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 497 (estimated) |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | October 10, 2025 |
| Main results expected | October 10, 2028 |
| Study ends | October 10, 2030 |
| Registry record updated | December 16, 2025 |
| Trial ID | NCT07283575 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with histologically confirmed recurrent or metastatic colorectal cancer who are planned to receive radiotherapy plus standard chemotherapy, with or without PD‑1 inhibitors, and who have an expected survival over six months are ideal candidates.
✕Probably not a fit
Patients who are not receiving radiotherapy, have uncontrolled central nervous system metastases, recent blood transfusion, active other malignancies within five years, or who are pregnant or breastfeeding may not benefit from this monitoring approach or be eligible for participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational, multicenter study enrolling adults with histologically confirmed recurrent or metastatic colorectal cancer who are eligible for radiotherapy combined with standard-of-care chemotherapy, with or without PD‑1 inhibitors. Participants will provide blood at baseline and at predefined timepoints during treatment for quantitative ctDNA methylation profiling. Standard imaging (CT or MRI) will be performed approximately every three months and clinical outcomes including response, time to recurrence, and survival will be recorded. The trial will correlate changes in plasma ctDNA methylation with imaging and clinical outcomes to explore its utility for monitoring treatment effect and predicting relapse.
Why it matters
Potential benefit: If successful, ctDNA methylation monitoring could detect treatment failure or relapse earlier and help personalize follow-up and therapy for patients with metastatic colorectal cancer.
How similar studies have gone: Prior work using mutation-based ctDNA has shown promise for monitoring colorectal cancer, and early studies of methylation-based ctDNA suggest potential but remain less mature and require further validation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years old, regardless of gender; 2. Histologically confirmed, recurrent or metastatic colorectal cancer; 3. Eligible to receive radiotherapy in combination with standard-of-care chemotherapy, with or without PD-1 inhibitors. 4. With expected survival of more than 6 months; 5. The subjects (or their legal representative / Guardian) must sign the informed consent form, indicating that they understand the purpose of the study, understand the necessary procedures of the study, and are willing to participate in the study. Exclusion Criteria: 1. Blood transfusion performed during operation or within 2 weeks before operation; 2. Pregnant or lactating women who have fertility and do not take adequate contraceptive measures; 3. Have a history of other malignant tumors within 5 years, except cured cervical carcinoma in situ or non melanoma skin cancer; 4. Primary brain tumor or central nerve metastasis is not under control, with obvious intracranial hypertension or neuropsychiatric symptoms; 5. Patients with the following serious or uncontrollable diseases: severe heart disease, the condition is still unstable after treatment, including myocardial infarction, congestive heart failure, unstable angina pectoris, pericardial effusion with obvious symptoms or unstable arrhythmia within 6 months before enrollment; definite neuropathy or psychosis, including dementia or seizures; severe or uncontrolled infection; active disseminated intravascular coagulation and obvious bleeding tendency; 6. Significant impairment of important organ function; 7. Other conditions in which the investigator believes that the patient should not participate in this trial.
Where it's running
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Fudan University Shanghai Cancer Center
Shanghai, China Recruiting
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.