NCT05154812Unknown早期 1 期
Based on the Comprehensive Evaluation System of Platelet Count/Splenic Length-diameter Ratio to Explore the Efficacy of Yang Yin Fu Zheng Jie Du Therapy in Delaying the Progression of HBV Associated Hepatocellular Carcinoma
Beijing Ditan Hospital1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2020年10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
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Tumor progression rate
研究概览
简要总结
Clinical research of Yang Yin Fu Zheng Jie Du therapy in HBV associated Hepatocellular Carcinoma based on the platelet count/splenic length-diameter ratio.The purpose of this study is to establish the efficacy evaluation system combined with platelet/splenic length-diameter ratio, and to clarify the effect of this method on relieving hepatitis B cirrhosis and delaying the progression of Hepatocellular Carcinoma.
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
- 是
入选标准
- •Meet the criteria of hepatocellular carcinoma Patients who tested positive for hepatitis B surface antigen (HBsAg) for >6 months Liver function grade child-Pugh A/B Patients who have agreed to select local treatment according to the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2017) TCM syndrome differentiation belongs to deficiency of qi and Yin, stasis and toxin accumulation syndrom Informed consent from the patient.
排除标准
- •Patient with other hepatitis virus infections or alcoholic liver, autoimmunity liver, primary biliary cirrhosis, genetic metabolic liver disease, and previous liver transplantation; Serious problem of heart, lung, brain, blood and other important organs; Patients with metastatic liver cancer; Pregnant or child breast feeding women; Mental or cognitive disorders; 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)
Routine medical care
Placebo Comparator
干预措施: Routine medical care (Drug)
结局指标
主要结局
Tumor progression rate
时间窗: 1 year
次要结局
- Complete response rate(1 year)
- Overall survival rate(1 year)
- Progression-free survival rate(1 year)
- Median time to tumor progression(1 year)
- the platelet count/splenic length-diameter ratio(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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