A Prospective, Multicenter, Open-labeled, Parallel -Controlled Clinical Study Investigating Huaier Granule for Prevention of Disease Progression of Hepatocarcinoma After Non-radical Hepatectomy
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 790
- 试验地点
- 1
- 主要终点
- Time to significant progression after surgery and postoperative survival period.
研究概览
简要总结
To evaluate the efficacy and safety of Huaier Granule for prevention of disease progression of hepatocarcinoma after non-radical hepatectomy.
详细描述
A Prospective, Multicenter, Open-labeled, Parallel -controlled Clinical Study, to evaluate the efficacy and safety of Huaier Granule for prevention of disease progression of hepatocarcinoma after non-radical hepatectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Age: ≥ 18 and ≤ 75 years, both male and female;
- •Non-radical hepatectomy has been performed for hepatocellular carcinoma;
- •The hepatocellular carcinoma has been confirmed by pathological examination;
- •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 ≤2 ULN, 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, neutrophil count> 1.5×109/L;
- •The expected survival time ≥12 weeks;
- •The subjects volunteer to sign the informed consent.
排除标准
- •Non-hepatocellular carcinoma patients;
- •Those who received radical hepatectomy;
- •Those with hepatic decompensation;
- •Pregnant or lactating women;
- •Those with HIV infection or AIDS-associated diseases;
- •Those with severe acute and chronic diseases, such as infection, diabetes cardiac insufficiency, pulmonary insufficiency, renal insufficiency;
- •Those who can not take drugs by oral route; or those develop serious adverse drug reaction;
- •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
Test group
Test group: Adjuvant therapy + Huaier Granule group.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 144 weeks after surgery or until study termination Adjuvant therapy: the adjuvant therapies are not limited, and for example, all the following treatments can be applied according to the individual's condition and guidelines of the research center: ablation therapy, immunotherapy, chemotherapy, radiotherapy, and Chinese herbs, as well as programs and medications that are used for post-operative liver protection and antiviral treatment
干预措施: Huaier Granule (Drug)
结局指标
主要结局
Time to significant progression after surgery and postoperative survival period.
时间窗: 3 years
Time to significant progression after surgery, including recurrence of local tumor, intrahepatic and extrahepatic metastasis, etc; and to evaluation of postoperative survival period.
次要结局
- ECOG and QLQ-C30 scores(Week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144)
- Alpha-fetoprotein quantitation and related biochemical indicators(Week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144)
- Iconography assessment(Week 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144)