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临床试验/NCT02449967
NCT02449967撤回1 期

HepaSphere Interventional Therapy Using Digital Subtraction Angiography(DSA) for Pancreatic Cancer: Clinical Trial

Fuda Cancer Hospital, Guangzhou1 个研究点 分布在 1 个国家开始时间: 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
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

Experimental

pancreatic cancer patients received HepaSphere interventional therapy using the digital subtraction angiography(DSA)

干预措施: interventional therapy (Procedure)

control

No Intervention

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)

研究者

发起方
Fuda Cancer Hospital, Guangzhou
申办方类型
Other
责任方
Sponsor

研究点 (1)

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