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A phase 2, Single-Arm study of oral fecal microbiota transplantation in advanced hepatocellular carcinoma after progression on ICI-TKI therapy

NCT ID NCT06563947

NEW Sponsor: Xu Yong, MD 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Last updated Sep 10, 2026

Summary

This prospective, single-center, single-arm phase 2 study evaluates the efficacy and safety of adding oral fecal microbiota transplantation (FMT) capsules to continued immune checkpoint inhibitor (ICI) plus tyrosine kinase inhibitor (TKI) therapy in adults with advanced hepatocellular carcinoma (HCC) whose disease has progressed during ICI-TKI therapy.

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 30 people

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

Started

Sep 2024

Expected to finish

Nov 2027

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: 1. Age 18-75 years old, gender is not limited; 2. Confirmed imaging or histological diagnosis of unresectable HCC, BCLC stadium B or C; 3. Clinical diagnosis of HCC progression during TKIs combined with ICIs treatment; 4. Not suitable for local ablation or chemoembolization; 5. Child-Pugh class A or B, with a score of ≤7; 6. ≥ 1 measurable lesion (RECIST v1.1) 7. ECOG PS 0-2 Exclusion Criteria: 1. Use of antibiotics within 4 weeks prior enrollment; 2. Diagnosis of immunodeficiency (e.g. HIV, immunosuppressants) 3. Patients with known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 4. Female patients who are pregnant or breastfeeding; 5. Patients with untreated acute or chronic active hepatitis B or hepatitis C infection. 6. Patients are currently undergoing clinical trials of other drugs; 7. Patients are considered by the investigator to be unsuitable for inclusion.

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma

As listed by the trial registrant

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

Advanced hepatocellular carcinoma

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

  • Shenzhen Third People's Hospital

    RECRUITING

    Shenzhen, 518112, China

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