NCT00257426已完成2 期
A Phase II Study of Octreotide Acetate for the Treatment of Advanced or Metastatic Hepatocellular Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Median survival
研究概览
简要总结
RATIONALE: Octreotide may stop or slow the growth of tumor cells and may be an effective treatment for liver cancer.
PURPOSE: This phase II trial is studying how well octreotide works in treating patients with locally advanced or metastatic liver cancer.
详细描述
OBJECTIVES:
Primary
- To verify that long-acting somatostatin analog octreotide (Sandostatin LAR) depot will extend median survival from 5 months to 8.75 months in patients with locally advanced or metastatic hepatocellular carcinoma with a CLIP score of 3 or more.
Secondary
- To document tolerability of this drug in this patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Median survival
时间窗: 6 months
次要结局
- number of subjects with toxicities(6 months)
研究者
研究点 (2)
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