Hepatocellular carcinoma
Conditions
Interventions
Transcatheter arterial chemoembolization with miriplatin
Sponsors
Kyoto Prefectural University of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven or clinically diagnosed hepatocellular carcinoma 2) Typical features of hepatocellular carcinoma as assessed by dynamic computed tomography or magnetic response imaging (ie, hypervascular with washout in the portal/venous phase) 3) No indication for surgical resection or liver transplantation 4) ECOG Performance Status 0-1 5) Adequate organ function a) Neutrophil>=1500 /mm3 b) Hb>= 9.0 g/dL c) PLT>= 50000 /mm3 d) T-Bil<= 3.0 mg/dL e) Albumin>= 2.8 g/dL f) AST<= within 5 times of normal limit g) ALT<= within 5 times of normal limit h) Cre<= within 1.5 times of normal limit 6) Child-Pugh A or B 7) Adequate indication for TACE 8) Interval of at least 4 weeks between last treatment and start of present treatment 9) Life expectancy of at least 8 weeks 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Refractory pleural effusion or ascites 2) Encephalopathy 3) Concurrent disease a) Serious hypertension b) Severe heart disease c) Acute myocardial infarction within 6 months prior to inclusion d) Active double cancer e) Severe mental disorder f) Allergic reaction to iodine contrast material g) Severe drug allergy 4) Intrahepatic or portal-caval shunts 5) Tumor thrombosis in main portal vein or vena cava 6) Pregnant and lactating females; females of childbearing age unless using effective contraception 7) Patients who are concluded to be inappropriate to participate in this study by their physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival, Child-Pugh status progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival, Tumor response, Safety | — |
Countries
Japan
Outcome results
None listed