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

Hepatocellular Carcinoma Clinical Trial

Official title: 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 Recruiting

Clinical Trial 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.

Clinical Trial 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 respond 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 IIa, 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. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

• NCT number: NCT05750030
• Study type: Interventional
• Source: Medical University of Vienna
• Contact: Matthias Pinter, MD PhD
• Phone: +43140400
• Email: matthias.pinter@meduniwien.ac.at
• Status: Recruiting
• Phase: Phase 2
• Start date: May 16, 2023
• Completion date: January 2026