NCT06563947
Oral Fecal Microbiota Transplantation in Advanced Hepatocellular Carcinoma After Progression on ICI-TKI Therapy
At risk: Primary completion moved 12 months later, primary endpoint(s) modified.
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Record History
All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗
Notable Primary completion pushed from May 20, 2026 to May 20, 2027v2 Show 10 more changesShow less
- Primary endpoint(s) modified
- Recruitment opened
- Eligibility criteria expanded, about 7 words
- Study completion pushed from Nov 20, 2026 to Nov 20, 2027
- Interventions modified
- Study sites: 0 to 1
- Start date changed from estimate of Aug 24, 2024 to Sep 3, 2024
- Secondary endpoints expanded, about 15 words
- Study description expanded, about 43 words
- Study title expanded, about 5 words
- Study First Submitted
- Notable: the plan changed
Endpoints
Primary
Progression-Free Survival (PFS)
Timeframe: From the first dose of FMT capsules to radiographic disease progression or death, up to approximately 1 year
Secondary (4)
Overall Survival (OS)
Objective Response Rate (ORR)
Duration of Response (DOR)
Disease Control Rate (DCR)
Arms and interventions
Oral Fecal Microbiota Transplantation Plus Continued ICI-TKI TherapyExperimental
Participants continue their pre-enrollment ICI-TKI regimen and receive oral fecal microbiota transplantation (FMT) capsules (300 mg per capsule) at 6 capsules per day for 10 consecutive days in each 21-day cycle, for a total of 4 cycles.
Biologicals: Oral fecal microbiota transplantation capsules
Sites
1 site in 1 country
- Shenzhen Third People's HospitalShenzhen, China