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临床试验/JPRN-UMIN000005910
JPRN-UMIN000005910已完成1 期

Safety Evaluation of the Maintenance treatment of Sorafenib in Hepatocellular carcinoma patients with Tumor thrombus after palliative surgery - Sorafenib for TT

Tokyo University Hospital0 个研究点目标入组 12 人开始时间: 2011年7月6日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
12

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 85years-old(—)
性别
All

入选标准

  • 未提供

排除标准

  • (1)Patients treated with sorafenib or other molecular target drugs within 3 months before surgery; (2)Patients with a history of allergic reaction to sorafenib; (3)Pregnant and breastfeeding women or those who may possibly be pregnant; (4)Patients with serious complications (whether preoperative or postoperative); (5)Patients with distant metastasis; (6)Patients with other active malignancies (e.g., brain tumor); (7)Patients with underlying diseases other than viral hepatitis (e.g., autoimmune hepatitis, alcoholic hepatitis); (8)Patients with moderate or severe renal dysfunction (eGFR < 30 mL/min) including those on dialysis; (9)Patients with asthma; (10)Patients with uncontrolled hypertension or with thromboembolism, ischemic heart disease, unstable angina pectoris, heart failure, or cerebrovascular disorder that may affect the operability of the disease; (11)Patients with clinically relevant ascites (refractory ascites requiring therapeutic paracentesis); (12)Patients with previous liver transplantation; (13)Patients with esophageal varices that may cause bleeding (those who had gastrointestinal bleeding in the past month); (14)Patients with a current or past history of hepatic encephalopathy; (15)Patients under treatment with drugs affecting the activity of CYP3A4 or UGT1A9 (e.g., rifampicin) or drugs that may affect the serum concentration of sorafenib; (16)Patients orally taking crude drugs approved for the treatment of cancer (e.g., Sho-saiko-to); (17)Patients with diseases related to human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS); or (18)Patients considered to be ineligible for participation in the study by the investigator or subinvestigator.

研究者

发起方
Tokyo University Hospital

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