Oral Fecal Microbiota Transplantation in Advanced Hepatocellular Carcinoma After Progression on ICI-TKI Therapy

September 6, 2026 updated by: Xu Yong, MD

A Phase 2, Single-Arm Study of Oral Fecal Microbiota Transplantation in Advanced Hepatocellular Carcinoma After Progression on ICI-TKI Therapy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a prospective, single-center, single-arm clinical study evaluating the efficacy and safety of oral fecal microbiota transplantation (FMT) capsules in patients with advanced hepatocellular carcinoma (HCC) whose disease has progressed during immune checkpoint inhibitor (ICI) plus tyrosine kinase inhibitor (TKI) therapy.

After enrollment, participants will continue the same ICI-TKI regimen according to its prescribed schedule. In addition, oral FMT capsules (300 mg per capsule) will be administered at 6 capsules per day for 10 consecutive days in each 21-day cycle, for a total of 4 cycles. ICI-TKI therapy will continue until disease progression, unacceptable toxicity, withdrawal of consent, or another protocol-defined discontinuation criterion.

The primary endpoint is progression-free survival (PFS), defined as the time from the first dose of FMT capsules to the first documented radiographic disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.

Secondary endpoints include overall survival (OS), defined as the time from the first dose of FMT capsules to death from any cause; objective response rate (ORR), defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) according to RECIST version 1.1; duration of response (DOR), defined for participants with CR or PR as the time from the first documented response to radiographic disease progression or death from any cause, whichever occurs first; and disease control rate (DCR), defined as the proportion of participants with CR, PR, or stable disease (SD) according to RECIST version 1.1.

Adverse events will be evaluated and graded according to CTCAE version 5.0. Other assessments include protocol-specified imaging, laboratory tests, and quality-of-life measures.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Shenzhen, China, 518112
        • Recruiting
        • Shenzhen Third People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Oral Fecal Microbiota Transplantation Plus Continued ICI-TKI Therapy
Participants continue their pre-enrollment ICI-TKI regimen and receive oral fecal microbiota transplantation (FMT) capsules (300 mg per capsule) at 6 capsules per day for 10 consecutive days in each 21-day cycle, for a total of 4 cycles.
Biological: Oral fecal microbiota transplantation capsules
Oral fecal microbiota transplantation capsules (300 mg per capsule) are administered at a dose of 6 capsules per day for 10 consecutive days in each 21-day cycle, for a total of 4 cycles. Participants continue their pre-enrollment ICI-TKI regimen during FMT treatment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: From the first dose of FMT capsules to radiographic disease progression or death, up to approximately 1 year
Time from the first dose of FMT capsules to the first documented radiographic disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.
From the first dose of FMT capsules to radiographic disease progression or death, up to approximately 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From the first dose of FMT capsules to death from any cause, up to approximately 1 year
Time from the first dose of FMT capsules to death from any cause.
From the first dose of FMT capsules to death from any cause, up to approximately 1 year
Objective Response Rate (ORR)
Time Frame: From the first dose of FMT capsules through approximately 1 year
Proportion of participants with a best overall response of complete response or partial response according to RECIST version 1.1.
From the first dose of FMT capsules through approximately 1 year
Duration of Response (DOR)
Time Frame: From the first documented response to disease progression or death, up to approximately 1 year
For participants with a complete or partial response, time from the first documented response to radiographic disease progression or death from any cause, whichever occurs first.
From the first documented response to disease progression or death, up to approximately 1 year
Disease Control Rate (DCR)
Time Frame: From the first dose of FMT capsules through approximately 1 year
Proportion of participants with a best overall response of complete response, partial response, or stable disease according to RECIST version 1.1.
From the first dose of FMT capsules through approximately 1 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gut microbiome diversity by shotgun metagenomic sequencing
Time Frame: Up to approximately 1 year
Longitudinal fecal samples will be analyzed by shotgun metagenomic sequencing to assess alpha diversity, beta diversity, and changes in overall gut microbial community structure.
Up to approximately 1 year
Gut microbiome taxonomic and functional profiling by shotgun metagenomic sequencing
Time Frame: Up to approximately 1 year
Longitudinal fecal samples will be analyzed by shotgun metagenomic sequencing to characterize microbial taxonomic composition and functional pathways, and to evaluate treatment-associated changes over time.
Up to approximately 1 year
Single-cell transcriptomics
Time Frame: Up to approximately 1 year
Single-cell RNA sequencing will be used to characterize cell populations, cellular states, and treatment-associated transcriptional changes.
Up to approximately 1 year
Plasma metabolomics
Time Frame: Up to approximately 1 year
Longitudinal plasma samples will be analyzed by mass spectrometry-based metabolomic profiling to identify treatment-associated changes in metabolites and metabolic pathways.
Up to approximately 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xu Yong, MD

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nanjing Xiershou Biotechnology Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yong Xu, Dr, Secretary of the Party Committee of the Shenzhen Third People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 3, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 20, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 20, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY2024-178

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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