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

PHASE2RecruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

July 16, 2025

Primary Completion Date

March 31, 2028

Study Completion Date

March 31, 2028

Conditions
ImmunotherapyHCC - Hepatocellular Carcinoma
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.

Trial Locations (7)

45147

NOT_YET_RECRUITING

University Hospital Essen, Essen

68167

NOT_YET_RECRUITING

University Hospital Mannheim, Mannheim

69120

RECRUITING

University Hospital Heidelberg, Heidelberg

72076

NOT_YET_RECRUITING

University Hospital Tübingen, Tübingen

86156

NOT_YET_RECRUITING

University Hospital Augsburg, Augsburg

89081

NOT_YET_RECRUITING

University Hospital Ulm, Ulm

93053

NOT_YET_RECRUITING

University Hospital Regensburg, Regensburg

All Listed Sponsors
collaborator

National Center for Tumor Diseases, Heidelberg

OTHER

collaborator

German Cancer Research Center

OTHER

collaborator

Heidelberg University

OTHER

collaborator

University of Cologne

OTHER

collaborator

Universitätsmedizin Mannheim

OTHER

lead

Michael Dill

OTHER

NCT05690048 - Fecal Microbiota Transfer in Liver Cancer to Overcome Resistance to Atezolizumab/Bevacizumab (FLORA) | Biotech Hunter | Biotech Hunter