At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Confirmed radiologic or histological diagnosis of HCC
- ✓Disease not amenable to resection, liver transplantation or loco-regionary therapy
- ✓Eligible for therapy with Atezolizumab / Bevacizumab according to standard of care
- ✕Use of immunosuppressive medication within 6 months prior to first dose
- ✕Active or prior documented autoimmune or inflammatory disorders
- ✕Prior exposure to immune-mediated therapy including anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-VEGF antibodies
- ✕Known to have tested positive for HIV infection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Fecal Microbiota Transfer in Liver Cancer to Overcome Resistance to Atezolizumab/Bevacizumab (FLORA)
In Brief
A Phase 2 clinical trial evaluating Fecal microbiota transfer, Vancomycin Oral Capsule, and 3 other interventions for Immunotherapy and HCC - Hepatocellular Carcinoma. Currently recruiting, targeting 48 participants across 7 sites.
Detailed 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.
Study Details
Timeline
Interventions
FMT via capsule (50 g of fecal matter) on day 0 and day 21.
Vancomycin orally (250 mg 4xd, day -3 to 0).
Atezolizumab 1200mg i.v. \& Bevacizumab 15mg/kg body weight i.v. (A/B) as standard of care (SOC).
Placebo Vancomycin orally (4xd, day -3 to 0).
Placebo Fecal microbiota transfer (FMT) via capsule on day 0 and day 21.