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
Xu Yong, MD
30 participants
Sep 3, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
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.
Locations(1)
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NCT06563947