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

Sponsor
Michael Dill
Study ID
NCT05690048
Phase
PHASE2
Status
Recruiting
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Conditions

  • HCC - Hepatocellular Carcinoma
  • Immunotherapy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fecal microbiota transfer — DRUG
    FMT via capsule (50 g of fecal matter) on day 0 and day 21.
  • Vancomycin Oral Capsule — DRUG
    Vancomycin orally (250 mg 4xd, day -3 to 0).
  • Atezolizumab + Bevacizumab — DRUG
    Atezolizumab 1200mg i.v. \& Bevacizumab 15mg/kg body weight i.v. (A/B) as standard of care (SOC).
  • Placebo Vancomycin Oral Capsule — DRUG
    Placebo Vancomycin orally (4xd, day -3 to 0).
  • Placebo Fecal microbiota transfer — DRUG
    Placebo Fecal microbiota transfer (FMT) via capsule on day 0 and day 21.

Study Details

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 Dates

Start date
Jul 16, 2025
Status verified
Aug 2025
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Vancomycin + A/B + FMT
    1. Atezolizumab 1200mg i.v. \& Bevacizumab 15mg/kg body weight i.v. (A/B) as standard of care (SOC). 2. Vancomycin orally (250 mg 4xd, day -3 to 0) for reduction of original patient gut microbiota. 3. Fecal microbiota transfer (FMT) via capsules (total 50 g of fecal matter) on day 0 and day 21.
  • Placebo Comparator: Placebo Vancomycin + A/B + Placebo FMT
    1. Atezolizumab 1200mg i.v. \& bevacizumab 15mg/kg body weight i.v. (A/B) as standard of care (SOC). 2. Placebo vancomycin orally (4xd, day -3 to 0) for reduction of original patient gut microbiota. 3. Placebo fecal microbiota transfer (FMT) via capsules on day 0 and day 21.

Primary Outcome Measure

Assessment of immunogenicity [ Time Frame: 6 weeks after treatment initiation ]

Central Contacts

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