Patients with hepatocellular carcinoma (HCC) beyond Milan Criteria (MC) who are transplant-eligible will be treated with 6 months of neoadjuvant/downstaging atezolizumab plus bevacizumab while receiving standard of care transarterial chemoembolization (TACE). We hypothesize that atezolizumab and bevacizumab can appropriately bridge patients with HCC beyond MC to transplantation and not increase the risk of 1-year post-transplant rejection.
Male or female, aged ≥18 years old at the time of signing Informed Consent Form
Measurable or evaluable disease per RECIST v1.1 or mRECIST of unresectable HCC outside of Milan criteria
Histologically proven HCC, without extrahepatic disease. Patients who consent to a fresh tissue biopsy, and under the discretion of the Investigators, will provide a baseline biopsy sample for diagnosis and correlative studies. Archival tumor tissue may be used to confirm HCC in patients who do not consent to a fresh tissue biopsy.
Prior remote LRT is allowed if new lesions or local disease recurrence are present
Known fibrolamellar HCC, sacromatoid HCC, or mixed cholangiocarcinoma and HCC
Previous systemic therapy for HCC prior to study enrollment
Planned or prior multi-organ transplant or prior solid organ or allogeneic stem cell transplantation
History of Grade ≥4 venous thromboembolism
Single group
Atezolizumab
Drug1200 mg administered every three weeks for up to 6 months (up to 8 cycles) during the liver transplant waiting period
Bevacizumab
Drug15 mg/kg administered every three weeks for up to 6 months (up to 8 cycles) during the liver transplant waiting period
Proportion of Patients Receiving Liver Transplant Experiencing Acute Rejection
The proportion of liver transplant patients who have acute allograft rejection
Proportion of participants who experience treatment-emergent adverse events
Number of patients who experience an FDA-defined adverse event due to the experimental treatment
Objective Response Rate
Combined incidence of partial response and complete response of tumors to therapy per RECIST criteria
Proportion of participants who are removed from the liver transplant waiting list after initiating the atezolizumab/bevacizumab therapy
Number of participants who had been on the liver transplant waitlist but are removed
The proportion of participants who proceed to liver transplantation
Participants who receive a liver transplant
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The Methodist Hospital Research Institute
Lead sponsor
Genentech, Inc.
Collaborator
