Abstract
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.
Keywords:
HCC; PD-1; hepatocellular carcinoma; tislelizumab.
Publication types
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Clinical Trial, Phase III
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Multicenter Study
MeSH terms
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Adult
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Aged
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Antineoplastic Agents, Immunological / administration & dosage
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Antineoplastic Agents, Immunological / adverse effects
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Antineoplastic Agents, Immunological / therapeutic use*
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B7-H1 Antigen / antagonists & inhibitors
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Carcinoma, Hepatocellular / drug therapy*
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Carcinoma, Hepatocellular / metabolism
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Carcinoma, Hepatocellular / mortality
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Carcinoma, Hepatocellular / pathology
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Female
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Humans
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Induction Chemotherapy
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Liver Neoplasms / drug therapy*
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Liver Neoplasms / metabolism
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Liver Neoplasms / mortality
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Liver Neoplasms / pathology
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Male
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Middle Aged
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Neoplasm Metastasis
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Neoplasm Staging
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Protein Kinase Inhibitors / administration & dosage
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Protein Kinase Inhibitors / adverse effects
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Protein Kinase Inhibitors / therapeutic use*
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Sorafenib / administration & dosage
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Sorafenib / adverse effects
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Sorafenib / therapeutic use*
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Treatment Outcome
Substances
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Antineoplastic Agents, Immunological
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B7-H1 Antigen
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CD274 protein, human
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Protein Kinase Inhibitors
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Sorafenib