Clinical trial · Interventional
Research on Colorectal Cancer Recurrence Monitoring and Individualized Treatment Based on MRD
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer (MSI-H) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Molecular Residual Disease | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Continued Immunotherapy | Other | — | UNRESOLVED |
| Discontinue NA Treatment | Other | — | UNRESOLVED |
| Observation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- MRD-Guided Treatment Discontinuation
- description
- 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.
- interventionNames
- Other: Discontinue NA Treatment
- type
- ACTIVE_COMPARATOR
- label
- Continued Immunotherapy
- description
- 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.
- interventionNames
- Other: Continued Immunotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available