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

Phase 2 Recruiting 48 enrolled Michael Dill German Cancer Research Center · collab Heidelberg University · collab National Center for Tumor Diseases, Heidelberg · collab University of Cologne · collab Universitätsmedizin Mannheim · collab

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2025-07-16
Primary completion: 2028-03
Completion: 2028-03

Publications

Rauber C, Roberti MP, Vehreschild MJ, Tsakmaklis A, Springfeld C, Teufel A, Ettrich T, Jochheim L, Kandulski A, Missios P, Mohr R, Reichart A, Waldschmidt DT, Sauer LD, Sander A, Schirmacher P, Jager D, Michl P, Dill MT. Protocol: Faecal microbiota transfer in liver cancer to overcome resistance to atezolizumab/bevacizumab - a multicentre, randomised, placebo-controlled, double-blind phase II trial (the FLORA trial). BMJ Open. 2025 Sep 9;15(9):e097802. doi: 10.1136/bmjopen-2024-097802.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MaaT013	Other / unclassified	50 g	Oral
Background	Atezolizumab	Monoclonal antibody	1200 mg	Intravenous
Background	Bevacizumab	Monoclonal antibody	15 mg/kg	Intravenous
Background	Vancomycin	Other / unclassified	250 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications