A Randomized Double-blind, Placebo-controlled Japanese Phase III Trial of ARQ 197 in Hepatocellular Carcinoma (HCC) (JET-HCC)
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The present clinical trial is aiming to evaluate efficacy of ARQ 197 in patients with hepatocellular carcinoma (HCC), who were resistant or intolerable to one systemic chemotherapy regimen including sorafenib.
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Layout table for eligibility information
Ages Eligible for Study:
20 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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)