NCT05750030

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

Fecal Microbiota Transplant (FMT) Combined With Atezolizumab Plus Bevacizumab in Patients With HepatoCellular Carcinoma Who Failed to Respond to Prior Immunotherapy - the FAB-HCC Pilot Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The main purpose of this phase IIa pilot study is to test the safety and efficacy of fecal microbiota transplant (FMT) combined with atezolizumab plus bevacizumab in patients who failed to achieve or maintain a complete or partial radiological response (according to mRECIST) to prior immunotherapy for advanced hepatocellular carcinoma (aHCC). The primary objective is to assess the safety of FMT combined with atezolizumab plus bevacizumab, as measured by incidence and severity of treatment-related adverse events. The secondary objectives are to assess the efficacy of FMT in combination with atezolizumab plus bevacizumab as measured by best radiological response, objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS). Furthermore, the objective is to evaluate the impact of FMT with atezolizumab plus bevacizumab on the quality of life, as assessed by EQ-5D-5L questionnaires. Finally, this study also aims to assess the following exploratory endpoints: * the effect of FMT on recipient gut microbiota composition, diversity, rate of change from baseline, and similarity to donor stool composition over time (compared between responders and non-responders) * the effect of FMT on immune activity in the gut * metagenome assemblies and functional profiling before and after FMT * single cell analyses of circulating immune cells before and after FMT * serum and stool metabolomic and lipidomic signatures before and after FMT This is a phase II, single-center, open-label pilot study. Twelve patients suffering from advanced-stage hepatocellular carcinoma will be enrolled in this trial. The planned duration for this study are 48 months.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-05-16
• Primary completion: 2025-03-17
• Completion: 2025-03-17
• First posted: 2023-03-01
• Last updated: 2025-05-06

Locations

1 site across 1 country: Austria