Atezolizumab and Bevacizumab Pre-Liver Transplantation for Patients with Hepatocellular Carcinoma Beyond Milan Criteria: A Feasibility Study

Investigator: Maen Abdelrahim, MD

Study Coordinator:

Status: Open Not Enrolling

ClinicalTrials.gov Number: N/A

Phone:

Protocol Number: PRO00032239

Description

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. The combination of atezolizumab with bevacizumab is expected to down-grade the tumor size and potentially allow patients to reach the smaller tumor criteria of MC for qualifying for exception points for a liver transplant. Even if the growth is halted and not reduced to MC, stable patients may be able to achieve liver transplant without exception points if a matching donor can be located that would not be suitable for another recipient. These extended criteria donor livers would be discarded yet have shown success in circumstances such as the purpose for the current trial. Liver transplantation provides the life-saving benefit and curative therapy for liver-limited HCC. Although there has been some success with therapeutics and LRT management for HCC, liver transplantation provides the highest survival outcome (85% at 5-yrs).
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