NCT03516071已完成2 期
A Multicenter, Randomized, Open-label, Phase II Clinical Study to Evaluate the Efficacy and Safety of Brivanib Alaninate (ZL-2301) Combined With Best Supportive Care (BSC) and Pharmacokinetic Profiles of Brivanib Alaninate in Patients With Advanced Hepatocellular Carcinoma (HCC) Failed or Intolerant of Standard Systemic Chemotherapy and/or Sorafenib
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 15
- 主要终点
- Disease control rate (DCR) at 3 months from randomization
研究概览
简要总结
This is a Phase 2, Open-label, Randomized, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Brivanib in Patients with Previously Treated Advanced Hepatocellular Carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years, male or female
- •Histologically or cytologically confirmed or the clinical diagnosis standard confirmed hepatocellular carcinoma (HCC) patients
- •Failure or intolerance to prior treatment with chemotherapy and/or targeted therapy
- •Liver function status Child-Pugh Class A or B (score≤7)
- •ECOG Performance Status score 0 or 1
- •Patients must have adequate bone marrow, renal and hepatic function
排除标准
- •Known history or symptomatic metastatic brain
- •Uncontrolled moderate and severe ascites
- •With bleeding tendency and thrombosis history
- •Known history of severe cardiovascular disease
- •Uncontrollable active infections (≥CTCAE Grade 2)
- •Pregnant or breastfeeding women
研究组 & 干预措施
Brivanib 800 mg, QD + BSC
Experimental
干预措施: Brivanib 800 mg, QD (Drug)
Brivanib 400 mg, BID + BSC
Experimental
干预措施: Brivanib 400 mg, BID (Drug)
结局指标
主要结局
Disease control rate (DCR) at 3 months from randomization
时间窗: 12 weeks from randomization
Defined as the percentage of patients with complete response, partial response, or stable disease at 12 weeks from randomization by RECIST v1.1.
Time to Progress (TTP)
时间窗: 12 weeks from randomization
Defined as the time from random assignment to radiologic disease progression.
次要结局
- Disease control rate (DCR) at 6 months from randomization(24 weeks from randomization)
- Progression-free survival (PFS)(24 weeks from randomization)
- Objective response rate (ORR)(24 weeks from randomization)
- Overall survival (OS)(24 weeks from randomization)
研究者
研究点 (15)
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