Fecal Microbiota Transfer in Liver Cancer to Overcome Resistance to Atezolizumab/Bevacizumab (FLORA)

• Status: Not yet recruiting
• Trial end date: 2027-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The interventional, randomized, placebo-controlled, single blind phase II-trial FLORA will assess safety and immunogenicity of fecal microbiota transfer in combination with standard of care immunotherapy in advanced hepatocellular carcinoma (HCC) in a parallel group design.

Subjects will be randomized 2:1 into either the FMT or placebo group.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Michael Dill
• Collaborators: German Cancer Research Center; Heidelberg University; National Center for Tumor Diseases, Heidelberg; Universitätsmedizin Mannheim; University of Cologne
• Treatments: Atezolizumab; Bevacizumab; Vancomycin

Criteria

Inclusion Criteria:

1. Age 18 years or older

2. Confirmed imaging or histological diagnosis of unresectable HCC, BCLC stadium C

3. ECOG performance status of 0-1

Exclusion Criteria:

1. Advanced liver cirrhosis (Child-Pugh Score C)

2. Diagnosis of immunodeficiency (e.g. HIV, immunosuppressants)

3. Usage of antibiotics within 2 weeks prior enrollment