Advanced Hepatocellular CarcinomaPhase 2NCT06563947
Oral Fecal Microbiota Transplantation in Advanced Hepatocellular Carcinoma After Progression on ICI-TKI Therapy
A Phase 2 study testing Oral fecal microbiota transplantation capsules in people with Advanced Hepatocellular Carcinoma, run by Xu Yong, MD at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Hepatocellular Carcinoma
- What is being tested?
- Oral fecal microbiota transplantation capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 3 Sep 2024to 20 Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years old, gender is not limited;
- Confirmed imaging or histological diagnosis of unresectable HCC, BCLC stadium B or C;
- Clinical diagnosis of HCC progression during TKIs combined with ICIs treatment;
- Not suitable for local ablation or chemoembolization;
- Child-Pugh class A or B, with a score of ≤7;
- ≥ 1 measurable lesion (RECIST v1.1)
- ECOG PS 0-2
Who cannot join
- Use of antibiotics within 4 weeks prior enrollment;
- Diagnosis of immunodeficiency (e.g. HIV, immunosuppressants)
- Patients with known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
- Female patients who are pregnant or breastfeeding;
- Patients with untreated acute or chronic active hepatitis B or hepatitis C infection.
- Patients are currently undergoing clinical trials of other drugs;
- Patients are considered by the investigator to be unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shenzhen Third People's Hospital
Shenzhen, 518112
Cineng Xu, Dr, +86 13530871434, 822265652@qq.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Advanced Hepatocellular Carcinoma
- Being tested
- Oral fecal microbiota transplantation capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral fecal microbiota transplantation capsulesBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Oral Fecal Microbiota Transplantation Plus Continued ICI-TKI Therapy | Experimental | 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. Receives: Biological: Oral fecal microbiota transplantation capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
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.
Measured: From the first dose of FMT capsules to radiographic disease progression or death, up to approximately 1 year
Secondary outcomes (4)
Overall Survival (OS)
Time from the first dose of FMT capsules to death from any cause.
Measured: From the first dose of FMT capsules to death from any cause, up to approximately 1 year
Objective Response Rate (ORR)
Proportion of participants with a best overall response of complete response or partial response according to RECIST version 1.1.
Measured: From the first dose of FMT capsules through approximately 1 year
Duration of Response (DOR)
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.
Measured: From the first documented response to disease progression or death, up to approximately 1 year
Disease Control Rate (DCR)
Proportion of participants with a best overall response of complete response, partial response, or stable disease according to RECIST version 1.1.
Measured: From the first dose of FMT capsules through approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start3 Sep 2024
- Primary completion20 May 2027 (estimated)
- Study completion20 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-center, open-label, single-arm phase 2 study. Participants continue their pre-enrollment ICI-TKI regimen and receive oral fecal microbiota transplantation (FMT) capsules at 6 capsules per day for 10 consecutive days in each 21-day cycle, for a total of 4 cycles.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xu Yong, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Xiershou Biotechnology Co., Ltd
- Responsible party
- Sponsor-investigator, Xu Yong, MD, Shenzhen Third People's Hospital
- Investigators
- Yong Xu, Dr, Principal investigator, Secretary of the Party Committee of the Shenzhen Third People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563947
- Sponsor's protocol ID
- KY2024-178
- Status last verified
- Sep 2026
- First submitted
- 14 Aug 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Single-Arm Study of Oral Fecal Microbiota Transplantation in Advanced Hepatocellular Carcinoma After Progression on ICI-TKI Therapy
- ClinicalTrials.gov ID
- NCT06563947
- Acronym / sponsor ID
- KY2024-178
- Conditions
- Advanced Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Xu Yong, MDUniversity, hospital or other
- Collaborators
- Nanjing Xiershou Biotechnology Co., Ltd
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- 20 May 2027 (estimated)
- Study completion
- 20 Nov 2027 (estimated)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-center, open-label, single-arm phase 2 study. Participants continue their pre-enrollment ICI-TKI regimen and receive oral fecal microbiota transplantation (FMT) capsules at 6 capsules per day for 10 consecutive days in each 21-day cycle, for a total of 4 cycles.
| Arm | Type | Receives |
|---|---|---|
| Oral Fecal Microbiota Transplantation Plus Continued ICI-TKI Therapy | Experimental | Biological: Oral fecal microbiota transplantation capsulesParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-75 years old, gender is not limited;
- Confirmed imaging or histological diagnosis of unresectable HCC, BCLC stadium B or C;
- Clinical diagnosis of HCC progression during TKIs combined with ICIs treatment;
- Not suitable for local ablation or chemoembolization;
- Child-Pugh class A or B, with a score of ≤7;
Key exclusion criteria (7 listed)
- Use of antibiotics within 4 weeks prior enrollment;
- Diagnosis of immunodeficiency (e.g. HIV, immunosuppressants)
- Patients with known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
- Female patients who are pregnant or breastfeeding;
- Patients with untreated acute or chronic active hepatitis B or hepatitis C infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral fecal microbiota transplantation capsulesOral 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. | Biological | Oral Fecal Microbiota Transplantation Plus Continued ICI-TKI Therapy |
Primary outcome
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.
4 secondary outcomes
Overall Survival (OS)
Time frame: 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
Duration of Response (DOR)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yong Xu, Dr principal investigator
Secretary of the Party Committee of the Shenzhen Third People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral fecal microbiota transplantation capsules in people with Advanced Hepatocellular Carcinoma, run by Xu Yong, MD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cineng Xu, Dr (13530871434, 822265652@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: From the first dose of FMT capsules to radiographic disease progression or death, up to approximately 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.