DRKS00000376已完成2 期
A Proof-of-concept Phase II Study to Evaluate Efficacy, Safety and Pharmacokinetics of 4SC-201 and the Treatment Combination of Sorafenib Plus 4SC-201 in Patients With Hepatocellular Carcinoma Exhibiting Progressive Disease Under Sorafenib Treatment. - SHELTER (Studien-Nr. / Study No. 4SC-201-1-2009)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 4SC AG
- 入组人数
- 57
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Advanced stage hepatocellular carcinoma.
- •- Exhibiting progressive disease under sorafenib treatment.
- •- Child-Pugh class A and B. Only patients with Child-Pugh index class B of not more than 7 will be included.
- •- ECOG performance status 0, 1 or 2.
- •- Precedent first-line treatment with sorafenib minimum continuous dosing of 400 mg per day for at least 8 weeks.
排除标准
- •- Previous or concurrent cancer that is distinct in primary site or histology from HCC, except for cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis and T1). Any cancer curatively treated > 3 years prior to entry is permitted.
- •- Renal failure requiring hemo- or peritoneal dialysis.
- •- Known central nervous system (CNS) tumors including symptomatic brain metastasis.
- •- Child-Pugh index class B in combination with more than slight ascites or hepatic encephalopathy > Grade I.
- •- Pregnant or breastfeeding women.
- •- Sorafenib intolerance.
- •- Major surgery within the last 4 weeks.
研究者
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