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临床试验/NCT02724358
NCT02724358已完成不适用

Rg3 in Combination With TACE in Hepatocellular Carcinoma Patients With High Expression of Notch1

Eastern Hepatobiliary Surgery Hospital1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2012年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
320
试验地点
1
主要终点
Overall Survival

研究概览

简要总结

In order to provide a new option for clinical anti-angiogenesis therapy in hepatoma, a randomized controlled study is planed to confirm the effect of Rg3 in combination with TACE on angiogenesis and tumor treatment in advanced hepatocellular carcinoma patients with high expression of Notch1.

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

入选标准

  • Pathologically confirmed hepatocellular carcinoma.
  • High expression of Notch1 in tumor tissues.

排除标准

  • no pathological evidence of HCC

研究组 & 干预措施

TACE

Experimental

iodized oil (5ml) + Pirarubicin (20mg)

干预措施: TACE (Procedure)

Rg3

Experimental

20mg, BID, maintained though Month 12

干预措施: Rg3 (Drug)

TACE + Rg3

Experimental

the combination of the treatments for the above two groups. Rg3 will be stopped on the day performing TACE.

干预措施: TACE + Rg3 (Other)

Control

Experimental

standard liver protective therapy

干预措施: protective therapy (Procedure)

结局指标

主要结局

Overall Survival

时间窗: 3 years

Time to progression

时间窗: 3 years

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 Hospital

Eastern Hepatobiliary Surgery Hospital

研究点 (1)

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