Seven years have passed since sorafenib was approved as a systemic chemotherapeutic agent that improves survival in patients with advanced hepatocellular carcinoma (HCC). Despite numerous studies over subsequent years aimed at developing novel molecular targeted agents, no new drugs have produced positive results to date. Because of the difficulties faced in developing novel agents, the patients selected for drug development trials have shifted from those with similar hepatic functions and tumor stages, as in conventional trials, to those with homogeneous biological characteristics based on biomarkers. In addition, a promising new strategy in the development of treatments for HCC is the emerging field of immuno-oncology. However, to reduce medical costs, it is necessary to take a broad perspective to drug development by, for example, incorporating new concepts such as a master protocol system.
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A 2015 study studied this question.