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Blood test may tell when to stop immunotherapy in colorectal cancer

NCT ID NCT07775950

Disease control Sponsor: Sun Yat-sen University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial tests whether a blood test that detects tiny traces of tumor DNA (called MRD) can help decide when it's safe to stop immunotherapy in people with advanced colorectal cancer. Patients who respond well to one year of immunotherapy and have two negative MRD tests will be randomly assigned to either continue treatment or stop and be closely monitored. The goal is to see if stopping earlier, guided by the blood test, can reduce side effects without worsening outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Immunotherapy (immune checkpoint inhibitors) with or without discontinuation based on molecular residual disease (MRD) testing
What this could lead to
If successful, this could lead to personalized treatment durations for colorectal cancer, reducing unnecessary side effects while maintaining disease control.
What could go wrong
The trial is relatively small and early, and MRD testing may not perfectly predict recurrence. Stopping immunotherapy could risk disease progression in some patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Dec 2034

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer (msi-H) Molecular residual disease

How to take part

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  1. The places running it

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  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

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