Hepatocellular carcinoma
Conditions
Sponsors
Hokkaido University Hospital
Sapporo city general hospital Hokkaido Gastroenterology Hospital Hospital Hakodate Hokkaido
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age >= 20 years at informed consent. 2) Patients diagnosed with hepatocellular carcinoma by histologycally or clinically (with diagnostic imaging and tumor makers), and No indication for surgical resection, local therapy. 3) Patients who have target lesions that can be measured with imaging CT or imaging MRI. At least one or more target regions are there that have no local therapy (surgery, radiation therapy, transarterial chemoembolization, transcatheter arterial infusion, radiofrequency ablation, percutaneous ethanol injection etc.). Regions are evaluated measurable judged to be progress after any local therapy. 4) No carry-over effect or adverse drug reaction of prior treatments. Make following intervals from previous treatments; 2 weeks from a surgery and percutaneous local therapy, 4 weeks from transarterial chemoembolization, transcatheter arterial infusion and radiations. 5) Child-pugh A 6) Performance status (ECOG scale):0 or 1 7) The function of the major organ is kept as satisfied by the following requirement. Within 14 days before study entry, Neutrophil >= 1,500/microL Platelets >= 50,000/microL Hemoglobin >= 10g/dL Total bilirubin < 2.0mg/dL AST or ALT <= 5 *Upper limit of Normal(ULN) Cr <= 1.5 *ULN 8) Patients are considered to keeping procedure of this study such as visit, compliance, having laboratory tests. 9) Patients with written informed consent it was based on the full understanding and free will of themselves after having detailed explanations of the study.
Exclusion criteria
Exclusion criteria: 11) Treatment with sorafenib or other molecular target drugs in past. 2) Any systemic chemotherapy in past. 3) Patients with ascites possessed clinical meaning. (Requiring drainage) 4) After liver transplantation 5) Esophageal varices with bleeding risk 6) Within 12 months before study entry, following events were happened; acute myocardial infarction, unstable angina, heart failure, cerebrovascular diseases. 7) Hepatic Encephalopathy. (Including as a previous disease) 8) Brain tumors. 9) Hemodialysis. 10) Gastrointestinal bleeding was happened within 1 month before study entry. 11) Active second primary malignancies. 12) Treating with CYP3A4 inducing agents. (rifampicin, phenobarbital, phenytoin, carbamazepine, dexamethasone etc.) 13) Patients with following complications; Arrhythmias coming under Grade2 or more of NCI CTCAE v4.0, uncontrolled hypertension 14) Contraindication of 5-FU and sorafenib 15) Patient with taking herbal medicine approved as a treatment of cancer. (shosaikoto, etc.) 16) Patients with infection of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) related diseases. 17) Any patients are considered unsuitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| occurrence of dose limiting toxicity | — |
Secondary
| Measure | Time frame |
|---|---|
| Adversed events Objective tumor response Change of tumor markers | — |
Countries
Japan
Contacts
Public ContactMitsuru Nakanishi
Hokkaido University Hospital The Third Department of Internal Medicine(Gastroenterology and Hematology)
Outcome results
None listed