JPRN-UMIN000006475招募中未知
Evaluation of the safety and efficacy of sorafenib therapy after TACE for unresectable hepatocellular carcinoma (multicenter study) - Investigation for safety and efficacy of Sorafenib TreatmEnt Post-TACE in HCC: i-STEP
Kagoshima University Medical and Dental Hospital0 个研究点目标入组 70 人开始时间: 2011年10月5日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 70
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 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Patients previously treated with sorafenib or other molecular-targeting therapy 2) Patients previously treated with systemic chemotherapy 3) Patients with clinically significant ascites (refractory ascites requiring paracentesis) 4) Patients with extra-hepatic metastases at the time of the index TACE (Chest CT must be performed for confirmation.) 5) Patients with vascular invasion of Vp3/4 and Vv2/3 at the time of the index TACE 6) Patients with diffuse lesions at the time of the index TACE 7) Patients with a history of liver transplant 8) Patients with potential bleeding from esophageal varices 9) Patients who experienced any of the following within 12 months prior to enrollment in this study 10) Patients with a current or past history of hepatic encephalopathy 11) Patients with a brain tumor 12) Patients undergoing dialysis 13) Patients who had gastrointestinal hemorrhage within the past month 14) Patients with multiple active cancers 15) Patients receiving CYP3A4 inducers (e.g., rifampicin) 16) Patients with serious comorbidities (NCI-CTCAE Ver. 4 Grade 2 or greater arrhythmia, uncontrolled hypertension) 17) Patients with a history of serious hypersensitivity to sorafenib 18) Patients taking oral herbal medicine approved for the treatment of cancer (e.g., Shosaikoto) 19) Patients with disorders related to human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) 20) Pregnant or breastfeeding patients 21) Other patients judged by the principal investigator or a co-investigator to be inappropriate to participate in this stud
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