A phase 1 study of 5-FU and sorafenib combination therapy in patients with hepatocellular carcinoma. Non-blind dosage gradual increase study - A phase 1 study of 5-FU and sorafenib combination therapy in patients with hepatocellular carcinoma. Non-blind dosage gradual increase study

Hokkaido University Hospital0 个研究点目标入组 0 人开始时间: 2010年10月3日最近更新: 2023年10月17日

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•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.

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