CTRI/2009/091/000276已完成3 期
A Randomized, Double-blind, Multi-center Phase III Study of Brivanib versus Sorafenib as First-line Treatment in Patients with Advanced Hepatocellular Carcinoma - CA182-033
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,714
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
入选标准
- •Histologic or cytologic confirmed diagnosis of HCC. Advanced HCC
- •Disease not eligible for surgical and / or locoregional therapies
- •Progressive disease after surgical and / or locoregional therapies
- •Child-Pugh Class A
- •ECOG performance status 0-1
- •Adequate hematologic, hepatic, and renal function
排除标准
- •Prior use of any systemic anti-cancer chemotherapy, immunotherapy or molecular targeted agents for HCC
- •History of active cardiac disease
- •Thrombotic or embolic events within the past 6 months
- •Any other hemorrhage/bleeding event >= CTCAE Grade 3 within 4 weeks except for esophageal or gastric varices
- •Inability to swallow tablets or untreated malabsorption syndrome
研究者
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