Colorectal Cancer (MSI-H)NCT07775950

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

A study testing Discontinue NA Treatment, Continued Immunotherapy and Observation in people with Colorectal Cancer (MSI-H) and Molecular Residual Disease, run by Sun Yat-sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Colorectal Cancer (MSI-H), Molecular Residual Disease
What is being tested?: Discontinue NA Treatment, Continued Immunotherapy and Observation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteChina
Study dates: 23 Jun 2026to 30 Dec 2034
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.
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).
Pregnancy or breastfeeding.

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Presence of a serious concurrent disease that, in the investigator's judgment, may substantially affect life expectancy or study participation.
Failure to provide written informed consent.
Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Binyi Xiao, M.D contact

+86-15800004780

xiaoby@sysucc.org.cn

China1 site, 1 recruiting

Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Binyi Xiao, M.D., +86-1580004780, xiaoby@sysucc.org.cn
Recruiting

Other trials in China

About this study

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: Colorectal Cancer (MSI-H), Molecular Residual Disease
Being tested: Discontinue NA Treatment, Continued Immunotherapy, Observation
Medical subject headings: Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Discontinue NA TreatmentOther
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 ImmunotherapyOther
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.
ObservationOther
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.

Study groups in NCT07775950
Study group	Role	What they receive
MRD-Guided Treatment Discontinuation	Experimental	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. Receives: Other: Discontinue NA Treatment
Continued Immunotherapy	Active comparator	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. Receives: Other: Continued Immunotherapy
Observational Cohort	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. Receives: Other: Observation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: From randomization to disease progression, death, or up to 2 years

Secondary outcomes (2)

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.
Measured: From randomization to death from any cause or up to 3 years
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.
Measured: From randomization through 2 years of follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jun 202630 Dec 2034

First posted20 Aug 2026
Study start23 Jun 2026
Primary completion30 Dec 2029 (estimated)
Study completion30 Dec 2034 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Colorectal Cancer (MSI-H)Studies of the same condition, open and under way.
More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07775950
Sponsor's protocol ID: G2025-013
Status last verified: Aug 2026
First submitted: 16 Aug 2026
Last updated: 20 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Binyi Xiao, M.D

+86-15800004780

xiaoby@sysucc.org.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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