hepatocellular carcinoma
Conditions
Sponsors
Kyowa Hakko Kirin Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Informed consent form 2) 20 years or older 3) Inoperable HCC which is not eligible for locoregional therapy 4) Diagnosed as c-Met high in tumor sample 5) Radiographic progression is confirmed during or after systemic chemotherapy including sorafenib, or those who are intolerance to the chemotherapy. 6) ECOG PS is 0 or 1 7) Child-Pugh Class A 8) Having measurable target lesions which are defined by RECIST version 1.1, 9) Negative pregnancy test results 10) Adequate organ function 11) Life expectancy of at least 12 weeks
Exclusion criteria
Exclusion criteria: 1) More than 2 prior systemic chemotherapy. 2) Prior therapy of c-Met inhibitor (including antibody) 3) Any systemic therapy within 2 weeks prior to the randomization 4) Locoregional therapy within 4 weeks prior to randomization. 5) Major surgery within 4 weeks prior to the randomization 6) Concurrent cancer within 5 years prior to the randomization 7) History of cardiac diseases 8) Active clinically serious infections defined as Grade 3 or higher according to CTCAE 4.0 9) Any psychological disorder affecting Informed Consent 10) Diagnosis positive for anti-HIV antibody and/or anti-HTLV-1 antibody 11) Blood or albumin transfusion within 14 days prior to the screening test 12) Concurrent interferon therapy against HBV/HCV 13) Symptomatic brain metastases 14) History of liver transplantation 15) Inability to swallow oral medications 16) Confirmed interstitial lung disease 18) Pleural effusion and/or clinically significant ascites 19) Pregnancy or breast-feeding 20) Without consent to effective single or combined contraceptive methods
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) Measurement of the period from randomization to progress disease or death | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Time to progression, Time to treatment failure, Anti-tumor activity, and Safety The date of the events was followed every three monthes after the end of the treatments of the study drug. | — |
Outcome results
None listed