NCT04264962已完成早期 1 期
Yang Yin Fu Zheng Jie Du Therapy in Recurrence of Hepatocellular Carcinoma Less Than 3 cm in Diameter
Beijing Ditan Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年1月1日最近更新:
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
- 300
- 试验地点
- 1
- 主要终点
- Recurrance rate
研究概览
简要总结
Clinical research of Yang Yin Fu Zheng Jie Du therapy in recurrence of Hepatocellular Carcinoma less than 3 cm in diameter.The purpose of this study is to observe the efficacy of routine medical care combined with Yang Yin Fu Zheng Jie Du therapy in 1 year recurrence for patients belong to Hepatocellular Carcinoma less than 3 cm in diameter.
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
- •Meet the criteria of hepatocellular carcinoma
- •Ages Eligible for Study: ≤75 years old;
- •The size of the main nodule and multi-centricity (single lesion, three nodules ≤3 cm)
- •After transarterial chemoembolisation (TACE) or radiofrequency ablation (RFA)
- •Surgery cannot be allowed;
- •Informed consent from the patient.
排除标准
- •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 Jie Du therapy
Experimental
干预措施: Yang Yin Fu Zheng Jie Du therapy (Drug)
Yang Yin Fu Zheng Jie Du therapy
Experimental
干预措施: Routine medical care (Other)
Routine medical care
Placebo Comparator
干预措施: Routine medical care (Other)
结局指标
主要结局
Recurrance rate
时间窗: 1 year
次要结局
- Objective response rate(1 year)
- quality of life (QOL) questionnaire(1 year)
研究者
Zhiyun Yang
Archiater, Professor
Beijing Ditan Hospital
研究点 (1)
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