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OncoMatch/Clinical Trials/NCT07775950

Research on Colorectal Cancer Recurrence Monitoring and Individualized Treatment Based on MRD

Is NCT07775950 recruiting? Yes, currently enrolling (Sep 2026). This NA trial studies non-drug interventions for colorectal cancer (msi-h).

NARecruitingSun Yat-sen UniversityNCT07775950Data as of Sep 2026Location: China

This study aims to evaluate whether plasma molecular residual disease (MRD), assessed using circulating tumor DNA (ctDNA), can help optimize the duration of immunotherapy in patients with metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colorectal cancer. Patients with MSI-H/dMMR metastatic colorectal cancer can achieve durable responses to immune checkpoint inhibitors, but the optimal duration of treatment remains uncertain. Prolonged immunotherapy may increase treatment burden and the risk of immune-related adverse events. ctDNA-based MRD testing may provide a sensitive method for detecting residual tumor burden and identifying patients who may be able to safely stop treatment. In this study, patients receiving immunotherapy will undergo serial plasma MRD testing. After completing 1 year of immunotherapy, patients with two consecutive negative MRD results will be randomly assigned to either continue immunotherapy or stop treatment and enter observation. Patients will then be followed every 3 months for 2 years with MRD testing and routine clinical assessments, including imaging and laboratory examinations. The study will compare clinical outcomes between the two groups and evaluate whether serial plasma MRD monitoring can support a more individualized approach to the duration of immunotherapy in MSI-H/dMMR metastatic colorectal cancer.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Biomarker criteria

Required: MLH1 loss

Required: MSH2 loss

Required: MSH6 loss

Required: PMS2 loss

Disease stage

Required: Stage IV

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: immunotherapy

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT07775950 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior immunotherapy disqualifies patients from enrollment.

Does this trial require MLH1?

Yes, MLH1 loss is a required biomarker for enrollment.

Does this trial require MSH2?

Yes, MSH2 loss is a required biomarker for enrollment.

Does this trial require MSH6?

Yes, MSH6 loss is a required biomarker for enrollment.

What disease stage is eligible?

Stage IV is required (metastatic disease required).

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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