Clinical Trial

Fecal Microbiota Transplantation in Reversing Drug Resistance in Unresectable HCC (TALENP004)

Not Yet Recruiting
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Summary
This study aims to evaluate the safety and efficacy of fecal microbiota transplantation (FMT) in reversing drug resistance to the triple therapy regimen in patients with unresectable hepatocellular carcinoma (HCC). The triple therapy consists of transarterial chemoembolization (TACE), lenvatinib, and Sintilimab. The study is a prospective, single-arm, multicenter clinical trial involving 15 participants with mid-to-late stage HCC that has progressed despite the triple therapy. FMT capsules will be prepared by matching the gut microbiome profiles of healthy donors to those of patients who achieved complete response (CR) with the triple therapy. The primary endpoints include objective response rate (ORR), treatment-related adverse events (AEs). Secondary endpoints will assess overall survival (OS), progression-free survival (PFS), and disease control rate (DCR), changes in gut microbiome, metabolomics, and immune subsets before and after FMT.
Trial Details
NCT Number NCT06643533
Lead Sponsor Fujian Provincial Hospital
Conditions Hepatocellular Carcinoma Non-resectable
Enrollment 15 participants
Start Date 2025-01-01
Primary Completion 2027-06-01 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-10-16