advanced hepatocellular carcinoma
Conditions
Interventions
Sorafenib Radiation
Sponsors
Department of Molecular Gastroenterology and Hepatology, 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 tumor thrombus as assessed by dynamic computed tomography or magnetic response imaging 3) No indication for surgical resection, liver transplantation, and local therapy 4) ECOG Performance Status 0-1 5) Child-Pugh classification A 6) Adequate organ function a) Neutrophil>=1500 /mm3 b) Hb>= 9.0 g/dL c) PLT>= 60000 /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 7) 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) Pregnant and lactating females; females of childbearing age unless using effective contraception 5) Patients who are concluded to be inappropriate to participate in this study by their physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Overall survival | — |
Countries
Japan
Outcome results
None listed