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Gut bacteria transplant may supercharge liver cancer immunotherapy

NCT ID NCT07690683

Disease control Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 08, 2026 · Last updated Jul 22, 2026 · Updated 3 times

Summary

This trial investigates whether transplanting healthy gut bacteria (fecal microbiota transplantation) can help immunotherapy work better in people with advanced liver cancer. Participants receive either a real transplant via colonoscopy or a sham procedure, alongside standard immunotherapy. The study aims to see if this approach can delay cancer progression.

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 transplantation (FMT)
What this could lead to
If it works, this could improve how well immunotherapy fights liver cancer, potentially slowing disease progression.
What could go wrong
This is an early, small study. FMT may not boost immunotherapy, and there are risks from the procedure and unknown effects on the gut.

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 52 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

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: * Age \>18 years; * Diagnosis of advanced or unresectable HCC; * Patients undergoing standard therapy with immune checkpoint inhibitors (ICIs); * Signed informed consent for study participation. Exclusion Criteria: * Presence of chronic intestinal diseases (e.g., inflammatory bowel disease, celiac disease); * Recent use of systemic antibiotics (within the previous 4-6 weeks); * Child-Pugh class \> B8, ECOG performance status \>1; * Any contraindication to colonoscopy.

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma liver cancer liver disorder Liver Neoplasms pediatric hepatocellular carcinoma

As listed by the trial registrant

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

Hepatocellular cancer Hepatocellular carcinoma Liver cancer Liver diseases

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

  • Fondazione Policlinico Universitaro A. Gemelli IRCSS,UOC Medicina Interna e Gastroenterologia,Largo A. Gemelli,

    Roma, Italy

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