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Oral Fecal Microbiota Transplantation in Advanced Hepatocellular Carcinoma After Progression on ICI-TKI Therapy
Sponsor: Xu Yong, MD
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.
Official title: A Phase 2, Single-Arm Study of Oral Fecal Microbiota Transplantation in Advanced Hepatocellular Carcinoma After Progression on ICI-TKI Therapy
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2024-09-03
Completion Date
2027-11-20
Last Updated
2026-09-10
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Shenzhen Third People's Hospital
Shenzhen, China