JPRN-UMIN000004315已完成3 期
Randomized Controlled Trial Comparing Efficacy of Sorafenib versus Sorafenib In combination with Low dose cisplatin /fluorouracil hepatic arterial InfUSion chemotherapy in Patients with Advanced Hepatocellular Carcinoma(SILIUS Phase III) - SILIUS Phase III
SILIUS Trial Group,Japan Ministry of Health, Labour and Welfare0 个研究点目标入组 190 人开始时间: 2010年10月4日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 190
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) Previous malignancy 2) Renal failure 3) Any heart disease as follows a) Congestive heart failure defined as NYHA class III or IV b) Active coronary artery disease or ischemic heart disease such as cardiac infarction within 6 months prior to screening c) Serious cardiac arrhythmia d) Serious hypertension 4) Active clinically serious infections except for HBV and HCV 5) Active chicken pox. 6) Auditory disorder. 7) Known history of HIV infection. 8) Known metastatic or meningeal tumors. 9) Extrahepatic tumor spread which affects patient's prognosis 10) History of seizure disorder. 11) Clinically significant gastrointestinal bleeding within 4 weeks prior to study entry. 12) Embolization or infarction such as transient ischemic disease, deep vein thrombosis, pulmonary embolization. 13) Any history of treatment as follows: a) Treatment with the agent which induces CYP3A4 b) Surgical procedure within 4 weeks prior to start of study drug c) History of organ allograft 14) Patients unable to swallow oral medications. 15) Gastrointestinal disease that may affect to the absorption of drug or pharmacokinetics. 16) Medication that may affect to the absorption of drug or pharmacokinetics. 17) Any disease or disorder that may affect the evaluation of study drug. 18) Entry to the other clinical trial within 4 weeks prior to entry to this study. 19) Pregnant or breast-feeding patients. 20) Known allergy to the investigational agent or any agent given in association with this trial. 21) Substance abuse, medical, psychological or social conditions that, in the judgment of the investigator, is likely to interfere with the patient's participation in the study or evaluation of the stuy results. 22) Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment.
研究者
相似试验
尚未招募
不适用
Comparison of efficacy of two insulin regimens in Patients of Acute Stroke with hyperglycemiaCTRI/2019/03/017919Smruti Babtiwale
招募中
2 期
Randomised Controlled Trial Comparing Efficacy of Zonisamide 25 mg given in addition to standard treatment with standard treatment alone in Tremor dominant Parkinsonâ??s Disease- A Pilot study.CTRI/2019/02/017634Sun Pharmaceutical Industries Ltd
已完成
不适用
Randomised Controlled Trial comparing the efficacy of Pidotimod versus placebo in children with persistent asthma.CTRI/2018/04/013405Postgraduate Institute Of Medical Education and Research79
尚未招募
不适用
Comparing midazolam to stop seizures when given through muscle versus when given through nose.CTRI/2018/10/016023AIIMS
招募中
不适用
Anti-fibrotic agent in Endonasal Lacrimal Sac Surgery.CTRI/2014/09/004989Hyderabad Eye Research Foundation440