NCT00152087Unknown2 期
Treatment of Unresectable Hepatocellular Carcinoma With Therasphere. A Human Device Evaluation Protocol.
St. Joseph's Hospital, Florida2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2002年10月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Efficacy
研究概览
简要总结
Surgical resection of the affected liver offers the best chance for disease-free survival in patients with Hepatoma (HCC). Unfortunately, most hepatoma patients present with disease which is multi-focal and thus not resectable. Fewer than 15% of HCC patients are resectable. The objective of treatment with TheraSphere is to selectively administer a dose of radioactive material directly to neoplastic tissue in the liver. Systemic therapy is largely ineffective.
详细描述
Protocol Objectives include:
- Determine the proportion of patients with HCC in whom the treatment plan can be completed
- Evaluate the response to therapy
- Evaluate toxicities and adverse experiences associated with TheraSphere treatment
- Evaluate survival time
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
- •Over 18 years of age of any sex, race
- •Histological proof of HCC
- •Able to give Informed Consent
- •ECOG performance equal or less than 2
- •Life expectancy equal to or greater than 3 months
- •Non- pregnant with acceptable contraception in premenopausal women
- •Greater than 4 weeks since prior radiation therapy or surgery
- •1 month post chemotherapy
- •Serum Bilirubin < 2.0
- •Acceptable white blood count
排除标准
- •Co-morbid disease that would place patient at undue risk.
- •Pre-existing diarrhea/illness
- •Fail preliminary MAA testing
结局指标
主要结局
Efficacy
- Response to treatment
- Survival time from treatment
Safety:
- Adverse experience
次要结局
未报告次要终点
研究者
研究点 (2)
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