NCT02523365已完成1 期
HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA） for Cervical Carcinoma: Clinical Trial
Fuda Cancer Hospital, Guangzhou1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of participants with Adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional therapy using digital subtraction angiography（DSA） for cervical carcinoma.
详细描述
By enrolling patients with cervical carcinoma adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of HepaSphere interventional therapy using digital subtraction angiography（DSA） for cervical 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Karnofsky performance status >60
- •Diagnosis of cervical carcinoma based on histology or the current accepted radiological measures.
- •Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
- •Will receive interventional therapy
- •Life expectancy: Greater than 3 months
- •Patients' routine blood test, liver function and kidney function have no obvious abnormalities
- •Ability to understand the study protocol and a willingness to sign a written informed consent document
排除标准
- •Patients with other primary tumor except cervical carcinoma
- •History of coagulation disorders or anemia
研究组 & 干预措施
HepaSphere
Experimental
cervical carcinoma patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）
干预措施: interventional therapy (Procedure)
control
Placebo Comparator
cervical carcinoma patients received traditional therapy
干预措施: interventional therapy (Procedure)
结局指标
主要结局
Number of participants with Adverse events
时间窗: 1 year
次要结局
- Percentage of lesions interventional therapy that show no sign of recurrence 12 months after(1 year)
- Overall survival (OS)(3 year)
- Progress free disease (PFS)(1 year)
研究者
研究点 (1)
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