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Could a short course of immunotherapy shrink colon cancer before surgery?

NCT ID NCT06830239

Disease control Sponsor: Universitaire Ziekenhuizen KU Leuven Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial is testing whether giving the immunotherapy drug dostarlimab before surgery can help shrink tumors in people with a specific type of stage III colon cancer (called pMMR/MSS). Ten participants will receive two doses of the drug over six weeks, then undergo surgery. The main goal is to study molecular changes in blood and tumor tissue that might predict a better response. While some patients may benefit, it is not yet known if this approach is better than surgery alone.

What this could mean

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

Active substance
dostarlimab (Jemperli), an immunotherapy drug that helps the immune system fight cancer
What this could lead to
If it works, this could point toward a way to shrink certain colon cancers before surgery, possibly improving outcomes for some patients.
What could go wrong
This is a very small, early-phase trial with only 10 people. It is not yet proven to work for this type of colon cancer, and there is a risk of side effects or that the cancer may not respond.

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 10 people

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

Started

Apr 2025

Expected to finish

Dec 2028

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: * at least 18 years of age and capable of giving informed consent * primary adenocarcinoma colon cancer than can be removed surgically, staged cT3-4, cN0-2, cM0 or stage III * tumour expresses an MMR proficient/microsatellite stable called MSS * tissue samples from tumour and colon mucosa available for molecular analyses * capable of receiving immunotherapy * adequate general health status and organ function (blood tests) Exclusion Criteria: * no prior cancer treatment * not pregnant and using effective contraception if applicable

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Conditions

The condition(s) this trial relates to.

colon carcinoma colonic neoplasm malignant colon neoplasm

As listed by the trial registrant

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

Colon cancer stage III

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

  • UZLeuven

    RECRUITING

    Leuven, 3000, Belgium

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