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Poop pills plus chemo: new hope for stubborn colon cancer?

NCT ID NCT07486492

Disease control Sponsor: The First Affiliated Hospital of Xiamen 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-phase trial tests whether transplanting gut bacteria from young donors (via capsules or a tube) can help immunotherapy work better in people with a type of advanced colorectal cancer that usually doesn't respond to immunotherapy. Ten patients who have already tried standard treatments will receive the bacteria transplant, a PD-1 inhibitor, and chemotherapy every two weeks for three months. The main goal is to check safety, but researchers will also track tumor shrinkage and survival.

What this could mean

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

Active substance
fecal microbiota transplant (FMT) from young donors, combined with a PD-1 inhibitor immunotherapy and FOLFIRI chemotherapy
What this could lead to
If it works, this could point toward a new way to make immunotherapy effective in a hard-to-treat type of colorectal cancer.
What could go wrong
This is a very early, small trial (10 people) focused on safety, not proof of benefit. The combination may cause serious side effects or fail to improve outcomes.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 10 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Jan 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 to 75 years

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: * Histologically or cytologically confirmed diagnosis of MSS mCRC * Experienced disease progression after first-line chemotherapy and targeted therapy * ECOG performance status of 0-1 Exclusion Criteria: * History of FMT * Severe organ dysfunction (heart, lung, liver, kidney) * Other malignancies, psychiatric disorders, pregnancy or lactation * Unable to provide informed consent

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Conditions

The condition(s) this trial relates to.

colorectal cancer

As listed by the trial registrant

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

Colorectal cancer metastatic Fecal microbiota transplantation

How to take part

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

  1. 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 ↗

  2. 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.

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