Klinische Studie
Fecal Microbiota Transfer in Liver Cancer to Overcome Resistance to Atezolizumab/Bevacizumab – A randomized, placebo-controlled, double-blind Phase II trial(FLORA)Fecal Microbiota Transfer in Liver Cancer to Overcome Resistance to Atezolizumab/Bevacizumab – A randomized, placebo-controlled, double-blind Phase II trial
Krankheitsentität(en)
Leber
StudientypInterventionsstudiePhase II
StudientypInterventionsstudiePhase II
Wesentliche EinschlusskriterienConfirmed HCC (either by imaging in a cirrhotic liver [liver lesions that show typ�ical features of HCC on IV contrast-enhanced CT or MRI scans, i.e., hypervas�cularity in the arterial phase with washout in the portal or the late venous phase]
or histopathologically from biopsy specimen or surgery).
Wesentliche AusschlusskriterienUse of immunosuppressive medication within 6 months prior to the first dose of
Atezolizumab / Bevacizumab. The following are exceptions to this criterion:
a. Intranasal, inhaled, topical steroids or local steroid injections (e.g. intra�articular injection).
b. Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of
prednisone or equivalent
c. Steroids as premedication for hypersensitivity reactions or as an anti�emetic.
2. Active or prior documented autoimmune or inflammatory disorders
Statusrekrutierend
Ansprechpartner & KontaktUniversitätsklinikum RegensburgInnere Medizin IStudienzentrale0941 9447063studienzentrum.innere1(at)ukr.de