NCT00225290终止3 期
Double-blind, Placebo-controlled, Randomized Phase III Trial of Oral Thalidomide in Advanced Hepatocellular Carcinoma With Poor Liver Reserve
TTY Biopharm1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2003年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
To compare the overall survival of thalidomide- and placebo-treated advanced HCC patients.
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
- Double
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with measurable, metastatic or locally advanced hepatocellular carcinoma
- •The diagnosis of HCC should be established either by cyto/histology
- •Patients must be > 20 years of age.
- •ECOG score <
- •Signed informed consent.
- •Female patients at child-bearing age must have negative pregnancy test.
排除标准
- •Patients with other systemic diseases which require concurrent usage of glucocorticosteroid or immunosuppressant agent(s) are not eligible.
- •Patients with advanced second primary malignancy are not eligible.
- •Patients with active infection are not eligible.
- •Patients with pregnancy or breast-feeding are not eligible.
- •Patients with brain metastases are not eligible.
结局指标
主要结局
overall survival
次要结局
未报告次要终点
研究者
研究点 (1)
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