Fecal Microbiota Transfer in Liver Cancer to Overcome Resistance to Atezolizumab/Bevacizumab (FLORA)
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The interventional, randomized, placebo-controlled, double-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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age 18 years or older
• Confirmed radiologic or histological diagnosis of HCC
• Disease not amenable to resection, liver transplantation or loco-regionary therapy
• Eligible for therapy with Atezolizumab / Bevacizumab according to standard of care
• Measurable disease per RECIST 1.1
• Preserved liver function with a Child-Pugh score A or B (maximally 7 points)
• Performance status ECOG 0-1
Locations
Other Locations
Germany
University Hospital Augsburg
NOT_YET_RECRUITING
Augsburg
University Hospital Essen
NOT_YET_RECRUITING
Essen
University Hospital Heidelberg
RECRUITING
Heidelberg
University Hospital Mannheim
NOT_YET_RECRUITING
Mannheim
University Hospital Regensburg
NOT_YET_RECRUITING
Regensburg
University Hospital Tübingen
NOT_YET_RECRUITING
Tübingen
University Hospital Ulm
NOT_YET_RECRUITING
Ulm
Contact Information
Primary
Michael T Dill, PhD
michael.dill@med.uni-heidelberg.de
06221 568611
Backup
Conrad Rauber, MD/PhD
conrad.rauber@med.uni-heidelberg.de
06221568611
Time Frame
Start Date: 2025-07-16
Estimated Completion Date: 2028-03
Participants
Target number of participants: 48
Treatments
Experimental: Vancomycin + A/B + FMT
1. Atezolizumab 1200mg i.v. \& Bevacizumab 15mg/kg body weight i.v. (A/B) as standard of care (SOC).~2. Vancomycin orally (250 mg 4xd, day -3 to 0) for reduction of original patient gut microbiota.~3. Fecal microbiota transfer (FMT) via capsules (total 50 g of fecal matter) on day 0 and day 21.
Placebo_comparator: Placebo Vancomycin + A/B + Placebo FMT
1. Atezolizumab 1200mg i.v. \& bevacizumab 15mg/kg body weight i.v. (A/B) as standard of care (SOC).~2. Placebo vancomycin orally (4xd, day -3 to 0) for reduction of original patient gut microbiota.~3. Placebo fecal microbiota transfer (FMT) via capsules on day 0 and day 21.
Related Therapeutic Areas
Sponsors
Collaborators: German Cancer Research Center, Heidelberg University, National Center for Tumor Diseases, Heidelberg, University of Cologne, Universitätsmedizin Mannheim
Leads: Michael Dill