NCT00044512已完成2 期
A Phase II Multicenter Uncontrolled Trial of Sorafenib (BAY43-9006) in Patients With Advanced Hepatocellular Carcinoma
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 137
- 主要终点
- Percentage of Participants for Each Type of Response
研究概览
简要总结
Evaluate anti-cancer activity (e.g. proportion of patients with confirmed complete response or partial response) in patients with advanced, inoperable biopsy-proven hepatocellular carcinoma.
详细描述
In addition to the key secondary outcome parameters the following exploratory parameters were evaluated in subpopulations:
- Pharmacokinetics (PK) profile of Sorafenib
- Plasma and tissue tumor biomarkers
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed primary hepatocellular carcinoma (HCC)
- •Inoperable disease (T2-T4, any N, M0 or M1) or refused surgery
- •Measurable disease
- •At least 1 bidimensionally measurable lesion of at least 2 cm by computed tomography (CT) scan or magnetic resonance imaging (MRI)
- •Presence of at least 1 of the following:
- •Alpha-fetoprotein greater than the upper limit of normal (ULN)
- •Hepatitis C antibody positive
- •Hepatitis B surface antigen positive
- •Child's Pugh class A or B
- •Candidate for systemic therapy
排除标准
- •Fibrolamellar disease mixed histology
- •Metastatic brain or meningeal tumors
研究组 & 干预措施
Sorafenib 400 mg b.i.d.
Experimental
Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
干预措施: Sorafenib (Nexavar, BAY43-9006) (Drug)
结局指标
主要结局
Percentage of Participants for Each Type of Response
时间窗: Until 30 days after termination of active therapy
Objective response rate of sorafenib assessed as the proportion of subjects with confirmed complete or partial response as per modified World Health Organization (WHO) criteria.
次要结局
- Duration of Response(up to 3 years later)
- Time to Response(up to 3 years later)
- Time to Progression(up to 3 years later)
- Duration of Stable Disease(up to 3 years later)
- Time to Minor Response(up to 3 years later)
- Duration of Minor Response(Time from MR to PD)
- Overall Survival(Start of treatment to death)
研究者
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