NCT02927626已完成早期 1 期
Clinical Research of Yang Yin Fu Zheng Therapy in HBV Associated Hepatocellular Carcinoma Basing on Immune Microenviroment
Beijing Ditan Hospital1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2016年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Survival rate
研究概览
简要总结
Clinical research of Yang Yin Fu Zheng therapy in HBV associated hepatocellular carcinoma basing on immune microenviroment.The purpose of this study is to observe the efficacy of routine medical care combined with Yang Yin Fu Zheng therapy for patients belong to HBV-HCC.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed of stage HBV-HCCⅡb、Ⅲa、Ⅲb;
- •Ages Eligible for Study: ≤75 years old;
- •TCM syndrome is deficiency of both Qi and Yin;
- •Confirmed of CHB;
- •Surgery cannot be allowed;
- •Informed consent from the patient.
排除标准
- •Patient with other chronic hepatopathy, such as AIH, NAFLD, ALD;
- •Serious problem of heart, lung, or kidney with severe dysfunction;
- •Pregnant or child breast feeding women;
- •Mental or cognitive disorders;
- •Participating in other drug trials;
- •Who are allergic to the study drug.
研究组 & 干预措施
Yang Yin Fu Zheng therapy
Experimental
干预措施: Yang Yin Fu Zheng therapy (Drug)
Yang Yin Fu Zheng therapy
Experimental
干预措施: Routine medical care (Drug)
Routine medical care
Placebo Comparator
干预措施: Routine medical care (Drug)
结局指标
主要结局
Survival rate
时间窗: 2 years
次要结局
- quality of life(QOL)(2 years)
- Objective response rate(2 years)
研究者
Zhiyun Yang
archiater,professor
Beijing Ditan Hospital
研究点 (1)
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