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临床试验/NCT00826384
NCT00826384已完成1 期

Phase 1,Single-blind, Randomized, Controlled Study to Evaluate the Safety and Effectivity of TACE Therapy of HCC(Hepatocellular Carcinoma) With Blocking Tumor Blood Temporarily and Enhancing Perfu

Eastern Hepatobiliary Surgery Hospital1 个研究点 分布在 1 个国家目标入组 352 人开始时间: 2008年10月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
352
试验地点
1
主要终点
Overall survival

研究概览

简要总结

According to radiology imaging, the patients of HCC are divided into two groups(hypovascular tumor group and moderately vascular tumor group). Every group is divided into TACE therapy with balloon catheter subgroup and regular TACE therapy subgroup. Patients take the TACE therapy each 45 days, and have MRI diffusion examine or CT one week before next therapy. All objects are observed until the end event happening or in the group for 6 months.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •sign the written informed consent form provided.
  • •diagnosed clinically as HCC,need to take TACE.

排除标准

  • •have had an allergic reaction following iodine.
  • •have been in any TACE or radiotherapy or biotherapy within 30 days before the study.
  • •HCC of diffuse type,failure of hepatic function, chronic illness or disease including failure of heart function, uncontrolled high blood pressure, heart disorders, serious infection, uncontrolled diabetes mellitus.

结局指标

主要结局

Overall survival

时间窗: 2010

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ShenFeng

vice president of the Eastern Hepatobiliary Surgery Hospotal

Eastern Hepatobiliary Surgery Hospital

研究点 (1)

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