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

NCT05690048 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-08-06

No results posted yet for this study

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.

Conditions

  • Immunotherapy
  • HCC - 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.

Sponsors & Collaborators

  • National Center for Tumor Diseases, Heidelberg

    collaborator OTHER

  • German Cancer Research Center

    collaborator OTHER

  • Heidelberg University

    collaborator OTHER

  • University of Cologne

    collaborator OTHER

  • Universitätsmedizin Mannheim

    collaborator OTHER

  • Michael Dill

    lead OTHER

Principal Investigators

  • Michael T Dill, PhD · University Hospital Heidelberg, Heidelberg, Baden-Württemberg 69120

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-16
Primary Completion
2028-03-31
Completion
2028-03-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05690048 on ClinicalTrials.gov