HepaSphere Interventional Therapy Using Digital Subtraction Angiography(DSA) for Pancreatic Cancer: Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 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 pancreatic cancer.
详细描述
By enrolling patients with pancreatic cancer 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 pancreatic cancer.
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 pancreatic cancer 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 pancreatic cancer
- •History of coagulation disorders or anemia
研究组 & 干预措施
HepaSphere
pancreatic cancer patients received HepaSphere interventional therapy using the digital subtraction angiography(DSA)
干预措施: interventional therapy (Procedure)
control
pancreatic cancer patients did not receive any interventional therapy
结局指标
主要结局
Number of participants with Adverse events
时间窗: 1 year
次要结局
- Progress free disease (PFS)(1 year)
- Percentage of lesions that show no sign of recurrence 12 months after interventional therapy(1 year)
- Overall survival (OS)(3 year)
