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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Xu Yong, MD • ClinicalTrials.gov ID: NCT06563947

Registry updated: 2026-09-10
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Description

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.

Interventions

  • Oral fecal microbiota transplantation capsules (Biological)
    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.

Eligibility criteria

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.

Conditions

Advanced Hepatocellular Carcinoma

Locations

  • Shenzhen Third People's Hospital — Shenzhen, China
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record