Fecal Microbiota Transfer in Liver Cancer to Overcome Resistance to Atezolizumab/Bevacizumab (FLORA)
Michael Dill
48 participants
Jul 16, 2025
INTERVENTIONAL
Conditions
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
Plain Language Summary
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Interventions
FMT via capsule (50 g of fecal matter) on day 0 and day 21.
Vancomycin orally (250 mg 4xd, day -3 to 0).
Atezolizumab 1200mg i.v. \& Bevacizumab 15mg/kg body weight i.v. (A/B) as standard of care (SOC).
Placebo Vancomycin orally (4xd, day -3 to 0).
Placebo Fecal microbiota transfer (FMT) via capsule on day 0 and day 21.
Locations(7)
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NCT05690048