A Randomized Double-blind, Placebo-controlled Japanese Phase III Trial of ARQ 197 in Hepatocellular Carcinoma (HCC)

Inclusion Criteria: * Informed consent form * ≥20 years old * Inoperable HCC which is not eligible for locoregional therapy * Diagnosed as c-Met high in tumor sample * Radiographic progression is confirmed during or after systemic chemotherapy including sorafenib, or those who are intolerance to the chemotherapy. * Eastern Cooperative Oncology Group Performance Status (ECOG PS) is 0 or 1 * Child-Pugh Class A * Having measurable target lesions which are defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, * Negative pregnancy test results * Adequate organ function * Life expectancy of at least 12 weeks Exclusion Criteria: * More than 2 prior systemic chemotherapy. * Prior therapy of c-Met inhibitor (including antibody) * Any systemic therapy within ≤2 weeks prior to the randomization * Locoregional therapy within ≤4 weeks prior to randomization. * Major surgery within ≤4 weeks prior to the randomization * Concurrent cancer within ≤5 years prior to the randomization * History of cardiac diseases * Active clinically serious infections defined as ≥ Grade 3 according to Common Toxicity Criteria for Adverse Effects (CTCAE) 4.0 * Any psychological disorder affecting Informed Consent * Diagnosis positive for anti-HIV antibody and/or anti-HTLV-1 antibody * Blood or albumin transfusion within ≤14 days prior to the screening test * Concurrent interferon therapy against Hepatitis B Virus (HBV)/ Hepatitis C Virus (HCV) * Symptomatic brain metastases * History of liver transplantation * Inability to swallow oral medications * Confirmed interstitial lung disease * Pleural effusion and/or clinically significant ascites * Pregnancy or breast-feeding * Without consent to effective single or combined contraceptive methods