Abstract

ABSTRACT There is an urgent need for new systemic therapies, as the prognosis of patients with HCC has remained poor even since the introduction of sorafenib, a tyrosine kinase inhibitor (TKI), as a standard treatment of this disease. Consequently, many clinical trials are currently being conducted to evaluate various molecular agents for HCC. Among the phase III studies currently underway, several clinical trials are evaluating TKIs or other molecular agents. These trials include those comparing agents with sorafenib as a first-line therapy for advanced HCC (e.g. brivanib and linifanib), those comparing agents with a placebo as a second-line therapy (e.g. brivanib, everolimus, and ramucirumab), those examining agents used in combination with transcatheter arterial embolization (e.g. brivanib and TSU-68), and those examining the use of adjuvant therapy after hepatic resection or local ablation therapy (e.g. sorafenib and NIK-333). In early-phase studies, many agents are being evaluated for the treatment of HCC around the world. The mainstreams of molecular therapy are currently TKI and monoclonal antibodies (mAb). Several clinical trials are also ongoing in Japan. TKI258, a multiple-target TKI is being compared with sorafenib as a first-line therapy in a randomized phase II (P-II) study. Axitinib, a TKI that inhibits multiple targets is being compared with a placebo as a second-line therapy in a randomized P-II study. E7080, a multi-kinase inhibitor is being tested in a P-II study. CS-1008, an mAb targeting the human death receptor 5, is being investigated in combination with sorafenib in a P-II study. GC33, an mAb that binds to the glypican-3 protein, is being evaluating in a P-II study. Z-208, a retinoic acid RAR alpha receptor agonist, is currently being evaluated in a phase I/II study. OPB-31121, a STAT3 inhibitor, is being studied in a phase I study. Some of these agents may contribute to changes in management strategies for HCC in the near future.

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