Atezolizumab and Bevacizumab in Combination With Y^90 Radioembolization in HCC for Liver Transplant

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai

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

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators