Posted: Monday, November 21, 2022
Maen Abdelrahim, MD, PhD, PharmB, of Houston Methodist Neal Cancer Center, and colleagues plan to combine the PD-L1–targeting monoclonal antibody atezolizumab with the VEGF inhibitor bevacizumab in patients with hepatocellular carcinoma who are transplant-eligible. During the 2022 Society for Immunotherapy of Cancer (SITC) Annual Meeting (Abstract 621), the investigators introduced the methodology of their clinical trial (ClinicalTrials.gov identifier NCT05185505).
The study authors hypothesized that combination atezolizumab and bevacizumab may allow these patients to eventually undergo transplantation without increasing the risk of rejection. At the time of this presentation at the SITC Annual Meeting, a total of 30 patients with hepatocellular carcinoma who are beyond Milan criteria and eligible for liver transplantation enrolled thus far. After 20 patients are deemed evaluable, an interim analysis will be performed to determine safety and feasibility.
Participants in this phase II study will be treated with 6 months of neoadjuvant/downstaging atezolizumab plus bevacizumab while also receiving transarterial chemoembolization. Atezolizumab will be administered intravenously at 1,200 mg, followed by 15 mg/kg of bevacizumab on the same day. The proposed regimen will be given every 3 weeks for up to eight cycles or 6 months.
Primary endpoints of this study include evaluating the safety and feasibility of transplantation after atezolizumab plus bevacizumab treatment among patients with hepatocellular carcinoma beyond Milan criteria. Secondary objectives consist of the objective response rates of patients enrolled in the study, disease-free survival at 1 year for those who undergo liver transplantation, and overall survival. Overall survival is defined as the time of study enrollment to death from any cause or the time of transplantation to death from any cause. Disease-free survival is defined as the time to disease recurrence or death, whichever is earlier, from the time of liver transplantation.
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