RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Sun Yat-sen University • ClinicalTrials.gov ID: NCT07775950

Registry updated: 2026-08-20

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

Discontinue NA Treatment (Other)
Patients with dMMR/MSI-H metastatic colorectal cancer who achieve an objective response after 1 year of immunotherapy and have two consecutive negative plasma MRD results will be randomized to discontinue immunotherapy. Patients will enter observation and undergo routine clinical and imaging assessments, with plasma MRD testing every 3 months until the study endpoint.
Continued Immunotherapy (Other)
Patients with dMMR/MSI-H metastatic colorectal cancer who achieve an objective response after 1 year of immunotherapy and have two consecutive negative plasma MRD results will be randomized to continue immunotherapy for a total treatment duration of 2 years. Patients will undergo routine clinical and imaging assessments, with plasma MRD testing every 3 months until the study endpoint.
Observation (Other)
Patients who achieve disease control for at least 6 months after immunotherapy will undergo plasma MRD testing and prospective follow-up. The study will not interfere with subsequent treatment decisions, including discontinuation or continuation of immunotherapy, surgery, or local treatment. Patients will undergo routine clinical follow-up and serial MRD monitoring according to the study schedule.

Eligibility criteria

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.

Conditions

Colorectal Cancer (MSI-H) Molecular Residual Disease

Locations

Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment