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

RecruitingNAAges 18 Years - anyAllSun Yat-sen University
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In plain words

What the trial is, and whether it could suit you

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 MR

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Voluntary participation in the study and provision of written informed consent. 2. Age ≥18 years at the time of signing informed consent. 3. Histologically confirmed colorectal adenocarcinoma with mismatch repair deficiency (dMMR) or microsatellite instability-high (MSI-H) status. 4. Clinically confirmed stage IV disease. 5. No prior immunotherapy for the current colorectal cancer. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 7. Availability of adequate pretreatment tumor tissue and peripheral blood samples for whole-exome sequencing (WES) and personalized circulating tumor DNA (ctDNA)/MRD analysis. 8. Life expectancy \>12 months. 9. Willing and able to comply with the study procedures and scheduled follow-up. Exclusion Criteria: 1. Presence of another malignancy. 2. Prior immunotherapy for the current stage IV colorectal cancer. 3. Organ transplantation within 3 months before enrollment. 4. History of blood transfusion within 3 months before enrollment. 5. Active, known, or suspected autoimmune disease, or evidence of active or chronic infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV). 6. Pregnancy or breastfeeding. 7. Presence of a serious concurrent disease that, in the investigator's judgment, may substantially affect life expectancy or study participation. 8. Failure to provide written informed consent. 9. Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.
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What it tests

  • Discontinue NA Treatment
  • Continued Immunotherapy
  • Observation
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Where

1 site
Sun Yat-sen University Cancer Center
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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