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RECRUITING
NCT05690048
PHASE2

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

Sponsor: Michael Dill

View on ClinicalTrials.gov

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

DRUG

Fecal microbiota transfer

FMT via capsule (50 g of fecal matter) on day 0 and day 21.

DRUG

Vancomycin Oral Capsule

Vancomycin orally (250 mg 4xd, day -3 to 0).

DRUG

Atezolizumab + Bevacizumab

Atezolizumab 1200mg i.v. \& Bevacizumab 15mg/kg body weight i.v. (A/B) as standard of care (SOC).

DRUG

Placebo Vancomycin Oral Capsule

Placebo Vancomycin orally (4xd, day -3 to 0).

DRUG

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