FMT in IT-refractory HCC - FAB-HCC Pilot Study
NCT05750030 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2025-05-06
Summary
This single-center, pilot study (phase IIa) will evaluate the safety, feasibility, and efficacy of FMT from patients with HCC who responded to PD-(L)1-based immunotherapy to patients with HCC who failed to respond to atezolizumab/bevacizumab.
Conditions
Interventions
- COMBINATION_PRODUCT
-
FMT combined with Atezolizumab plus Bevacizumab
Single FMT from patients with HCC who responded to PD-(L)1-based immunotherapy to patients with HCC who failed to achieve complete or partial response (according to mRECIST) to atezolizumab/bevacizumab. After single FMT, patients will continue to receive atezolizumab/bevacizumab every 21-days according to protocol.
Sponsors & Collaborators
-
Medical University of Vienna
lead OTHER
Principal Investigators
-
Matthias Pinter, MD PhD · Medical University of Vienna, Internal Medicine III, Department of Gastroenterology and Hepatology
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-05-16
- Primary Completion
- 2025-03-17
- Completion
- 2025-03-17
Countries
- Austria
Study Locations
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