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NCT05690048
Fecal Microbiota Transfer in Liver Cancer to Overcome Resistance to Atezolizumab/Bevacizumab (FLORA)
Conditions: Immunotherapy
Sex: All
Ages: 18 Years – N/A
Phase: PHASE2
Enrollment: 48
Sponsor: Michael Dill
Location: Germany
Summary
The interventional, randomized, placebo-controlled, single 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.
Eligibility Criteria
Inclusion Criteria:Age 18 years or olderConfirmed imaging or histological diagnosis of unresectable HCC, BCLC stadium CECOG performance status of 0-1Exclusion Criteria:Advanced liver cirrhosis (Child-Pugh Score C)Diagnosis of immunodeficiency (e.g.
HIV, immunosuppressants)Usage of antibiotics within 2 weeks prior enrollment
Source: ClinicalTrials.gov (NCT05690048). StuddyBuddy aggregates publicly available trial information.
