NCT07775950Recruiting
Research on Colorectal Cancer Recurrence Monitoring and Individualized Treatment Based on MRD
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 16 Aug 2026
- Start date
- 23 Jun 2026
- Primary completion date
- 30 Dec 2029
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Colorectal cancer
- NCT number
- NCT07775950
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 23 Jun 2026 to the primary completion date, 30 Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior immunotherapy for the current stage IV colorectal cancer.
- Organ transplantation within 3 months before enrollment.
- History of blood transfusion within 3 months before enrollment.
- Presence of a serious concurrent disease that, in the investigator's judgment, may substantially affect life expectancy or study participation.
Other illness
- Presence of another malignancy.
- 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).
- Failure to provide written informed consent.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.
Other
- Pregnancy or breastfeeding.
Who the study is looking for
- Voluntary participation in the study and provision of written informed consent.
- Age ≥18 years at the time of signing informed consent.
- Histologically confirmed colorectal adenocarcinoma with mismatch repair deficiency (dMMR) or microsatellite instability-high (MSI-H) status.
- Clinically confirmed stage IV disease.
- No prior immunotherapy for the current colorectal cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Availability of adequate pretreatment tumor tissue and peripheral blood samples for whole-exome sequencing (WES) and personalized circulating tumor DNA (ctDNA)/MRD analysis.
- Life expectancy \>12 months.
- Willing and able to comply with the study procedures and scheduled follow-up.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.