About this trial
A single institution, single arm, two-cohort feasibility trial to evaluate the combination of locoregional Y\^90 therapy with systemic atezolizumab and bevacizumab, in participants presenting with hepatocellular carcinoma (HCC) 1) within Milan Criteria (MC) with AFP ≥ 400 ng/ml as a means of bridge therapy prior to transplant, 2) beyond the Milan Criteria (MC) (within USCF DS criteria and all comers), as a means of downstaging prior to liver transplantation.
Eligibility criteria
Qualifiers
Signed Informed Consent Form
Age ≥18 years at time of signing Informed Consent Form
Ability to comply with the study protocol
Newly diagnosed, biopsy-proven hepatocellular carcinoma (HCC) that is histologically or cytologically confirmed
Disqualifiers
AFP ≥ 1000 ng/ml
Pathologically mixed tumors, vascular invasion or extra-hepatic disease based on cross-sectional imaging
History of leptomeningeal disease
Uncontrolled tumor-related pain
Trial design
Treatments tested in this trial
- Atezolizumab
- Bevacizumab
- Y^90 Radioembolization
Treatment groups
Sponsors and collaborators
Icahn School of Medicine at Mount Sinai
Lead sponsor
Genentech, Inc.
Collaborator