FMT in IT-refractory HCC - FAB-HCC Pilot Study

Sponsor
Medical University of Vienna
Study ID
NCT05750030
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FMT combined with Atezolizumab plus Bevacizumab — COMBINATION_PRODUCT
    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.

Study Details

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.

Key Dates

Start date
May 16, 2023
Status verified
May 2025
Primary completion
Mar 17, 2025
Completion
Mar 17, 2025

Study Design

Enrollment
12 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: FMT combined with Atezolizumab plus Bevacizumab

Primary Outcome Measure

Safety of atezolizumab/bevacizumab in combination with FMT, measured by incidence and severity of treatment-related adverse events, determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.5.0. [ Time Frame: 24 months ]

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