Hepatocellular carcinoma
Conditions
Sponsors
Hokkaido University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)At least 20 years old when consent is given 2)Histologically or clinically (imaging and tumor markers) diagnosed hepatocellular carcinoma found to be ineligible for resection or local treatment 3)Lesions measurable with contrast-enhanced CT or contrast-enhanced MRI 4)Child-Pugh class A 5)ECOG performance status (PS) of 0 or 1 6)Major organs functional, satisfying the following: In tests performed 14 or fewer days before enrollment: Neutrophil count >=1500/microL Platelet count >=50000/microL Hemoglobin >= 8.5 g/dL Total bilirubin < 2.0 mg/dL Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) <= 5 times the upper limit of the study center standard range Serum creatinine (Cr) <=1.5 times the upper limit of the study center standard range 7)Capable of complying with requirements about visit days, medication, and laboratory tests 8)The patient has been fully informed and has an adequate understanding about the study and has given voluntary written consent before participation
Exclusion criteria
Exclusion criteria: 1)History of use of Sorafenib or another molecular targeted drug 2)History of systemic chemotherapy 3)Clinically significant ascites (refractory ascites requiring drainage) 4)History of liver transplantation 5)Esophageal varices with the potential to bleed 6) Any of the following 12 or fewer months before enrollment in this research: Myocardial infarction, unstable angina, cardiac failure, cerebrovascular disorder 7)Concurrent or prior hepatic encephalopathy 8)Brain tumor 9)On dialysis 10)Gastrointestinal hemorrhage during past month 11)Active multiple cancer 12)On a CYP3A4 inducer (rifampicin, phenobarbital, phenytoin, carbamazepine, dexamethasone) or food including St. John's wort. 13) Any of the following concurrent diseases: Grade 2 or greater arrhythmia or poorly controlled hypertension according to the JCOG/JSCO Japanese translation of the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE v 4.0) 14)Contraindicated for any of the study drugs 15)Orally taking an herbal medicine approved for the treatment of cancer (e.g., shosaikoto) 16)Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) related disease 17) Otherwise found ineligible as a subject by the researcher
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| One-year survival | — |
Secondary
| Measure | Time frame |
|---|---|
| OS TTP RR/DCR Safety | — |
Countries
Japan
Contacts
Public ContactMakoto Chuma
Hokkaido University Hospital Department of Gastroenterogy and Hematorogy
Outcome results
None listed