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

NCT05690048 Phase 2 RECRUITING

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.

Details

Lead sponsor	Michael Dill
Phase	Phase 2
Status	RECRUITING
Enrolment	48
Start date	2025-07-16
Completion	2028-03

Conditions

• Immunotherapy
• HCC - Hepatocellular Carcinoma

Interventions

• Fecal microbiota transfer
• Vancomycin Oral Capsule
• Atezolizumab + Bevacizumab
• Placebo Vancomycin Oral Capsule
• Placebo Fecal microbiota transfer

Primary outcomes

• Assessment of immunogenicity — 6 weeks after treatment initiation
  Tumoral CD8+ T cell infiltration after 2 cycles of treatment with Vancomycin, A/B + FMT in comparison to Vancomycin-placebo, A/B + FMT-placebo
• Safety of the therapeutic combination in advanced HCC — The observational period begins with the first administration of the 1st IMP (Vancomycin/Placebo) on day -3 and ends with either the Follow-up visit after 15 weeks (Day 105) or the initiation of a subsequent anticancer treatment.
  Occurence of Adverse Events (AE) \& immune-related adverse events (irAE)

Countries

Germany