A phase II clinical study of 5-FU and sorafenib combination therapy in patients with hepatocellular carcinoma. Uncontrolled exploratory clinical study - A phase II clinical study of 5-FU and sorafenib combination therapy in patients with hepatocellular carcinoma. Uncontrolled exploratory clinical study

Hokkaido University Hospital0 个研究点目标入组 98 人开始时间: 2012年10月15日最近更新: 2023年10月17日

适应症

试验速览

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•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

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