Research on Colorectal Cancer Recurrence Monitoring and Individualized Treatment Based on MRD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Presence of another malignancy.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Discontinue NA Treatment
Other interventionPatients 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 interventionPatients 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 interventionPatients 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.
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: MRD-Guided Treatment DiscontinuationExperimental treatment 1 intervention
Group B: Continued ImmunotherapyActive comparator 1 intervention
Group C: Observational CohortOther 1 intervention
Trial outcomes
Primary outcomes
1
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from randomization to the first documented disease progression or death from any cause, whichever occurs first. Participants without disease progression or death will be censored at the date of the last disease assessment.
Time frame
From randomization to disease progression, death, or up to 2 yearsSecondary outcomes
1
Overall Survival (OS)
Overall survival is defined as the time from randomization to death from any cause. Participants who are alive at the end of follow-up will be censored at the date they were last known to be alive.
Time frame
From randomization to death from any cause or up to 3 years2
Incidence of Immune-Related Adverse Events (irAEs)
The incidence of immune-related adverse events will be assessed during the study. The proportion of participants experiencing immune-related adverse events will be recorded and compared between the treatment-discontinuation and continued-immunotherapy groups.
Time frame
From randomization through 2 years of follow-upSponsors and contacts
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Source ClinicalTrials.gov