RATIONALE 301 Study: Tislelizumab Versus Sorafenib as First-Line Treatment for Unresectable Hepatocellular Carcinoma

作者：Shukui Qin, Richard S. Finn, Masatoshi Kudo, Tim Meyer, Arndt Vogel, Michel Ducreux, Teresa Macarulla, Gianluca Tomasello, Frédéric Boisserie, Jeannie Hou, Xin Li, James Song, Andrew X. Zhu · 发表于：Future Oncology · 年份：2019 · DOI：10.2217/fon-2019-0097 · 被引用次数：153 · 研究领域：Hepatocellular Carcinoma Treatment and Prognosis、Cancer Immunotherapy and Biomarkers、Cancer, Hypoxia, and Metabolism

Advanced, unresectable hepatocellular carcinoma (HCC) has a poor prognosis with median life expectancy of approximately 1 year. Overexpression of PD-L1 in tumor cells and PD-1 on tumor-infiltrating T cells has been associated with poorer prognosis, more advanced disease and higher recurrence rates in HCC. Monoclonal antibodies against PD-1 have demonstrated antitumor activity in patients with solid tumors, including HCC. Tislelizumab, an investigational, humanized IgG4 monoclonal antibody with high affinity and binding specificity for PD-1, has demonstrated preliminary antitumor activity in HCC. Here we describe a head-to-head Phase III study comparing the efficacy, safety and tolerability of tislelizumab with sorafenib as first-line treatment in unresectable HCC.