Atezolizumab and Bevacizumab Pre-Liver Transplantation for Patients With Hepatocellular Carcinoma Beyond Milan Criteria: A Feasibility Study
The Methodist Hospital Research Institute
Summary
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.
Description
Hepatocellular carcinoma (HCC) represents the second most common cause of cancer-related death and accounts for over 80% of primary liver cancers worldwide.(1) Curative treatment options include surgical resection in patients with well compensated liver function and radio frequency ablation in small tumors. However, in 90% of patients, HCC occurs in the setting of cirrhosis(2) where optimal management remains liver transplantation (LT) with 5-year survival rates of approximately 80%.(3) Despite the success of LT in treating HCC, only a small portion of patients fit into standard Milan Criteria…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female, aged ≥18 years old at the time of signing Informed Consent Form 2. Measurable or evaluable disease per RECIST v1.1 or mRECIST of unresectable HCC outside of Milan criteria 3. 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. 4. Prior remote LRT is allowed if new lesions or lo…
Interventions
- DrugAtezolizumab
1200 mg administered every three weeks for up to 6 months (up to 8 cycles) during the liver transplant waiting period
- DrugBevacizumab
15 mg/kg administered every three weeks for up to 6 months (up to 8 cycles) during the liver transplant waiting period
Location
- Houston Methodist Research InstituteHouston, Texas