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Fecal Microbiota Transfer in Liver Cancer to Overcome Resistance to Atezolizumab/Bevacizumab (FLORA)
Sponsor: Michael Dill
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2025-07-16
Completion Date
2028-03
Last Updated
2025-08-06
Healthy Volunteers
No
Interventions
Fecal microbiota transfer
FMT via capsule (50 g of fecal matter) on day 0 and day 21.
Vancomycin Oral Capsule
Vancomycin orally (250 mg 4xd, day -3 to 0).
Atezolizumab + Bevacizumab
Atezolizumab 1200mg i.v. \& Bevacizumab 15mg/kg body weight i.v. (A/B) as standard of care (SOC).
Placebo Vancomycin Oral Capsule
Placebo Vancomycin orally (4xd, day -3 to 0).
Placebo Fecal microbiota transfer
Placebo Fecal microbiota transfer (FMT) via capsule on day 0 and day 21.
Locations (7)
University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
University Hospital Augsburg
Augsburg, Germany
University Hospital Essen
Essen, Germany
University Hospital Mannheim
Mannheim, Germany
University Hospital Regensburg
Regensburg, Germany
University Hospital Tübingen
Tübingen, Germany
University Hospital Ulm
Ulm, Germany