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临床试验/JPRN-UMIN000005335
JPRN-UMIN000005335招募中1 期

A phase I study of sorafenib/UFT chemotherapy in advanced hepatocellular carcinoma - A phase I study of sorafenib/UFT chemotherapy in advanced hepatocellular carcinoma

Kyushu Univrsity Hospital0 个研究点目标入组 18 人开始时间: 2011年4月1日最近更新:
适应症

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
18

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
20years-old 至 80years-old(—)
性别
All

入选标准

  • 未提供

排除标准

  • 1) 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, etc.) 13) Patients with following complications; Arrhythmias coming under Grade2 or more of NCI CTCAE v4.0, uncontrolled hypertension 14) Contraindication of UFT 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 pregnant/ nursing 18)Those judged to be not suitable by the attending physician

研究者

发起方
Kyushu Univrsity Hospital

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