Recruiting nowNot phasedRandomised
What this trial is trying to do
The researchers are testing whether circulating tumour DNA (ctDNA)—small fragments of tumour DNA in the blood—can act as molecular residual disease (MRD) monitoring after one year of immunotherapy. In patients with metastatic MSI-high or mismatch-repair-deficient colorectal cancer who have two consecutive negative MRD tests, they will compare stopping immunotherapy with continuing it.
The idea is that a persistently negative MRD result may identify people who can stop treatment without shortening the time before the cancer progresses, while reducing treatment burden and immune-related side effects. The main comparison is progression-free survival between stopping and continuing immunotherapy, not overall survival or cure.
Worth knowing: This is a relatively small, non-blinded trial, and its stop-treatment question applies only to patients with metastatic MSI-high or mismatch-repair-deficient disease who have completed a year of immunotherapy and have two consecutive negative MRD tests.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT07775950 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Not phased |
| Design | randomised, open label |
| Taking part | 100 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Sun Yat-sen University |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Other Discontinue NA Treatment
- Other Continued Immunotherapy
- Other Observation
What it is measuring
Progression-Free Survival (PFS)
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Not phased. Not a drug-phase trial. Often a device, a procedure, or a change in how care is delivered.
How the researchers describe it
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.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- dMMR / MSI-H
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
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.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: China.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07775950, registered by Sun Yat-sen University on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.