A Multicenter, Randomized, Paralleled Control Clinical Study Investigating Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma After Radical Hepatectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,044
- 试验地点
- 1
- 主要终点
- Incidence of Recurrence and Metastasis After Hepatectomy
研究概览
简要总结
To evaluate the efficacy and safety of Huaier Granule for prevention of recurrence and metastasis of hepatocarcinoma after radical hepatectomy.
详细描述
A Multicenter, Randomized, Paralleled control Clinical Study Investigating Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma after Radical Hepatectomy,to evaluate the efficacy and safety.
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
- Double (Participant, Investigator)
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
- •Age: ≥ 18 and ≤ 75 years, both male and female;
- •Radical hepatectomy has been performed for hepatocellular carcinoma;
- •The hepatocellular carcinoma has been confirmed by pathological examination;
- •Barcelona clinic liver cancer(BCLC) stage A or B;
- •Not receiving any preoperative anticancer drug;
- •The liver and kidney function satisfies the following conditions within 15 days after surgery (excluding day 15): aspartate aminotransferase(AST), glutamic-oxalacetic transaminase(ALT)<3 upper limit of normal(ULN), total bilirubin≤2ULN, serum creatinine <1.5 ULN;
- •Other laboratory tests meet the following requirements within 15 days after surgery (excluding day 15): Hb≥9g/dl, platelet count≥60×109/L, absolute neutrophil count>1.0×109/L;
- •The expected survival time ≥ 12 weeks;
- •The subjects volunteer to sign the informed consent.
排除标准
- •Hepatocellular carcinoma patients who received non-radical hepatectomy;
- •Non-hepatocellular carcinoma patients;
- •Those with Child-Pugh C;
- •Pregnant or lactating women;
- •Those with active bleeding due to various reasons;
- •Those with HIV infection or AIDS-associated diseases;
- •Those with severe acute and chronic diseases;
- •Those with severe diabetes;
- •Those with serious infectious diseases;
- •Those who can not take drugs by oral route;
- •Drug abusers or those with psychological or mental diseases that may interfere with study compliance;
- •Conditions that are considered not suitable for this study investigators
研究组 & 干预措施
Huaier Granule group
Huaier Granule group; specifications: 20g / bag; manufacturer: Qidong Gaitianli Medicines Co., Ltd..
Administration: the Huaier Granule Electuary should be orally taken from the 15th day after surgery. Usage: Huaier Granule Electuary is continuously taken three times per day, 20g per time, until 96 weeks after surgery or until study termination. The subjects should not take any other anticancer drugs or immunomodulatory agents, except for Huaier Granule.
干预措施: Huaier Granule (Drug)
结局指标
主要结局
Incidence of Recurrence and Metastasis After Hepatectomy
时间窗: Week 94 after took medicine
At week 94 after took medicine, assess incidence of recurrence and metastasis after hepatectomy.
次要结局
- Postoperative Survival Period(Week 94 after took medicine)