JPRN-UMIN000004316已完成2 期
Phase II study: Transcatheter Arterial Chemoembolization Therapy In Combination with Sorafenib (TACTICS) - TACTICS
Japan Liver Oncology Group0 个研究点目标入组 228 人开始时间: 2010年10月4日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 228
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) History of malignant tumor 2) Severe cardiac disease 3) Serious and active infection, except for HBV and HCV 4) History of HIV infection 5) Renal dialysis 6) Diffuse tumor lesion 7) Extrahepatic metastasis 8) Vascular invasion 9) Intracranial tumor 10) Preexisting or history of hepatic encephalopathy 11) Clinically uncontrolled ascites or pleural effusion 12) Clinically severe gastrointestinal bleeding within 4 weeks of the start of treatment 13) Esophageal and/or gastric varices which has high risk of bleeding 14) History of thrombosis and/or embolism within 6 months of the start of treatment 15) History of receiving any of the following therapies: a) Systemic chemotherapy for advanced HCC b) Local therapy, such as radiofrequency ablation, TACE, or hepatic arterial infusion within 3 months of the start of treatment c) Current treatment with CYP3A4 inducing agents d) Invasive surgery within 4 weeks of the start of treatment e) History of allogenic transplantation f) History of bone marrow transplant or haemopoietic stem cell transplant within 4 weeks of the start of this study 16) Unable to take oral medications 17) Gastrointestinal problems that may affect absorption or pharmacokinetics of the study drugs 18) Use of drugs that may affect absorption or pharmacokinetics of the study drugs 19) Concurrent disease or disability that may affect evaluation of the effects of the study drugs 20) Enrollment in another study within 4 weeks of study entry 21) Female patients who are pregnant, lactating, possibly pregnant, or planning to become pregnant 22) Risk of allergic reactions to the study drugs 23) Drug abuse or other physical, psychological , or social problems that may interfere with the participation in the study or evaluation of study results 24) Any condition that could jeopardize the safety of the patient or their compliance in the study
研究者
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