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New combo therapy aims to shrink Hard-to-Treat colorectal tumors before surgery

NCT ID NCT07403877

Disease control Sponsor: Fudan University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether giving immunotherapy drugs (nivolumab with or without ipilimumab) or immunotherapy plus radiotherapy before surgery can improve outcomes for people with a specific genetic type of colorectal cancer called MSI-H/dMMR. About 114 participants will be randomly assigned to one of three treatment groups. The goal is to see which approach leads to more complete tumor shrinkage, potentially allowing some patients to avoid surgery altogether.

What this could mean

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

Active substance
nivolumab and ipilimumab (immunotherapy drugs), plus radiotherapy
What this could lead to
If successful, this could show that combining immunotherapy with or without radiotherapy before surgery helps shrink tumors more effectively in MSI-H colorectal cancer, potentially allowing some patients to avoid surgery.
What could go wrong
This is an early phase II trial with only 114 participants, so results may not apply to all patients. Immunotherapy can cause serious immune-related side effects, and adding radiotherapy may increase toxicity.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 114 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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. Histopathologically confirmed primary colorectal adenocarcinoma. 2. Radiographic assessment showed a stage II-III based on AJCC Stage 8th ed. 3. At least 18 years old. 4. MSI-H or dMMR. 5. The Eastern Cooperative Oncology Group performance status (ECOG PS) score is 0 or 1. 6. Physical state or organ function can tolerate the planned treatment of the study protocol. 7. Agreed to sign written informed consent before recruitment. Exclusion Criteria: 1. Previously received any antitumor therapy for the disease under study, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc. 2. Pregnancy or breastfeeding women. 3. History of other malignancies within 5 years. 4. Serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc. 5. Immunodeficiency disease or long-term using of immunosuppressive agents. 6. Allergic to any component of the therapy. 7. Any other condition or disease that is not suitable to take the therapy included in the protocol. 8. Concurrent participation in another clinical study, unless participating in an observational (non-interventional) clinical study or in the survival follow-up phase of an interventional study. 9. Received any investigational drug or device treatment within 4 weeks prior to initial administration of the investigational drug.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm mismatch repair cancer syndrome 1

As listed by the trial registrant

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

Colorectal cancer (msi-H)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fudan University Shanghai Cancer Center

    Shanghai, China

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