NCT06563947RecruitingPhase 2
Oral Fecal Microbiota Transplantation in Advanced Hepatocellular Carcinoma After Progression on ICI-TKI Therapy
A Phase 2, Single-Arm Study of Oral Fecal Microbiota Transplantation in Advanced Hepatocellular Carcinoma After Progression on ICI-TKI Therapy
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 14 Aug 2024
- Start date
- 3 Sept 2024
- Primary completion date
- 20 May 2027
- Lead sponsor
- Xu Yong, MD
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06563947
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 3 Sept 2024 to the primary completion date, 20 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of antibiotics within 4 weeks prior enrollment;
- Patients are currently undergoing clinical trials of other drugs;
Other illness
- Diagnosis of immunodeficiency (e.g. HIV, immunosuppressants)
- Patients with known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
- Patients with untreated acute or chronic active hepatitis B or hepatitis C infection.
Other
- Female patients who are pregnant or breastfeeding;
- Patients are considered by the investigator to be unsuitable for inclusion.
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shenzhen Third People's Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.