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Abstract Details
IMbrave 050: A Phase III Trial of Atezolizumab Plus Bevacizumab in High-Risk Hepatocellular Carcinoma After Curative Resection or Ablation
Stephen P Hack1, Jessica Spahn1, Minshan Chen2, Ann-Lii Cheng3, Ahmed Kaseb4, Masatoshi Kudo5, Han Chu Lee6, Adam Yopp7, Pierce Chow8, Shukui Qin9
Author information
1Genentech, Inc, 1 DNA Way, South San Francisco, CA 94080, USA.
2Department of Hepatobiliary Surgery, Cancer Centre of Sun Yat-sen University, Guangzhou, PR China.
3National Taiwan University Cancer Center & National Taiwan University Hospital, Taipei, Taiwan.
4Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA.
5Department of Gastroenterology & Hepatology, Kindai University School of Medicine, Osaka, Japan.
6Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
7Department of Surgery, Division of Surgical Oncology, University of Texas Southwestern Medical Center, Dallas, TX 75390, USA.
8Division of Surgical Oncology, National Cancer Centre, Singapore.
9PLA Cancer Center, People's Liberation Army (PLA) 81 Hospital, Nanjing 210016, PR China.
Abstract
Hepatocellular carcinoma recurs in 70-80% of cases following potentially curative resection or ablation and the immune component of the liver microenvironment plays a key role in recurrence. Many immunosuppressive mechanisms implicated in HCC recurrence are modulated by VEGF and/or immune checkpoints such as PD-L1. Atezolizumab (PD-L1 inhibitor) plus bevacizumab (VEGF inhibitor) has been shown to significantly improve overall survival, progression-free survival and overall response rate in unresectable HCC. Dual PD-L1/VEGF blockade may be effective in reducing HCC recurrence by creating a more immune-favorable microenvironment. We describe the rationale and design of IMbrave 050 (NCT04102098), a randomized, open-label, Phase III study comparing atezolizumab plus bevacizumab versus active surveillance in HCC patients at high-risk of recurrence following curative resection or ablation. The primary end point is recurrence-free survival. Clinical Trial Registration: NCT04102098.