Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06563947 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhasePhase 2
Started2024-09-03
View on ClinicalTrials.gov ↗
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.

Amendment history 5 changes detected by DataLookout

2026-09-11
Recruitment opened
2026-09-11
Primary endpoint(s) modified
WasDiversity analysis, Feces Metabolomics, Objective Objective Response Rate (ORR), Objective Progression-Free Survival (PFS), Objective Secondary Clinical Endpoints - Overall Growth Phase (OS), ObjectiveDuration of Response (DOR), Serum Metabolomics, Species differential analysis
NowProgression-Free Survival (PFS)
2026-09-11
Primary completion pushed: 2026-05-20 → 2027-05-20
2026-09-11
Completion pushed: 2026-11-20 → 2027-11-20
2026-09-11
Interventions modified
Trial Details
NCT Number NCT06563947
Lead Sponsor Xu Yong, MD
Collaborators: Nanjing Xiershou Biotechnology Co., Ltd
Conditions Advanced Hepatocellular Carcinoma
Enrollment 30 participants
Start Date 2024-09-03
Primary Completion 2027-05-20 (estimated)
Study Completion 2027-11-20 (estimated)
Updated on ClinicalTrials.gov 2026-09-10