Clinical Trial

PULSAR Combined With Fecal Microbiota Transplantation for Advanced Hepatocellular Carcinoma Progressing After First-Line Targeted-Immunotherapy

Not Yet Recruiting Phase 2
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Summary
This is an open-label, multicenter, randomized controlled Phase II trial. Patients with advanced hepatocellular carcinoma (HCC) who developed secondary resistance to first-line targeted-immunotherapy were randomly assigned to receive either the original first-line targeted-immunotherapy combined with FMT and PULSAR (experimental group), or second-line targeted-immunotherapy (control group). The first-line targeted-immunotherapy regimens consisted of tislelizumab combined with one of the first-line evidence-based tyrosine kinase inhibitors (TKIs), including lenvatinib, donafenib, apatinib, and sorafenib. Given that this study enrolled patients who progressed after an initial response to first-line targeted-immunotherapy, the second-line regimen in the control group continued tislelizumab immunotherapy while switching the TKI to regorafenib, an agent with second-line evidence.
Trial Details
NCT Number NCT07463248
Lead Sponsor Wang Xin
Conditions Hepatocellular Carcinoma (HCC)
Enrollment 64 participants
Start Date 2026-03-05
Primary Completion 2028-01-31 (estimated)
Study Completion 2029-01-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-11