NCT05690048

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Michael Dill · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Eligible HCC patients visiting the outpatient clinics at the study sites of the NCT Germany will be enrolled into the study after informed consent. Patients undergo 2:1 randomization into either the FMT or placebo group. Prior to the intervention, a sigmoidoscopy with mucosal biopsies will be performed. At day -3 to 0 oral Vancomycin 4x 250mg or placebo will be given. Atezolizumab/bevacizumab (A/B) will be administered as standard of care every 21 days, starting on day 0. At day 0 and 21, concurrent to the first and second cycle of A/B, encapsulated FMT or placebo will be administered on the same day. At day 40-42, before the third cycle of A/B, a tumor biopsy and a sigmoidoscopy will be performed. The first radiologic assessment will be performed after 4 cycles of A/B. Clinical efficacy and safety will be assessed as indicated per protocol analysis.

Conditions

• Immunotherapy
• HCC - Hepatocellular Carcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-16
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2023-01-19
• Last updated: 2025-08-06

Locations

7 sites across 1 country: Germany