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.
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
- Are there results?
- Not yet: the study is under way
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.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Binyi Xiao, M.D., +86-1580004780, xiaoby@sysucc.org.cn
About this study
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.
Read more
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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pei-Rong Ding, Sun Yat-sen University
- Investigators
- Peirong Ding, M.D., Principal investigator, Sun Yat-Sen University Cancer Center
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Colorectal Cancer Recurrence Monitoring and Individualized Treatment Based on MRD
- ClinicalTrials.gov ID
- NCT07775950
- Acronym / sponsor ID
- G2025-013
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 23 Jun 2026 (actual)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Dec 2034 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MRD-Guided Treatment Discontinuation | Experimental | Other: Discontinue NA TreatmentPatients 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 | Active comparator | Other: Continued ImmunotherapyPatients 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. |
| Observational Cohort | Other | Other: ObservationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Discontinue NA TreatmentPatients 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. | Other | MRD-Guided Treatment Discontinuation |
| Continued ImmunotherapyPatients 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. | Other | Continued Immunotherapy |
| ObservationPatients 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. | Other | Observational Cohort |
Primary outcome
Progression-Free Survival (PFS)
Time frame: From randomization to disease progression, death, or up to 2 years
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.
2 secondary outcomes
Overall Survival (OS)
Time frame: From randomization to death from any cause or up to 3 years
Incidence of Immune-Related Adverse Events (irAEs)
Time frame: From randomization through 2 years of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peirong Ding, M.D. principal investigator
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Binyi Xiao, M.D (+86-15800004780, xiaoby@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: From randomization to disease progression, death, or up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.