NCT02796820Unknown3 期
Huaier Granule As Adjuvant Therapy for Colorectal Cancer After Radical Surgery
Sixth Affiliated Hospital, Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2016年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Disease-free survival (DFS)
研究概览
简要总结
A randomized, paralleled control clinical study investigating Huaier Granule for prevention of recurrence and metastasis of colorectal cancer after radical surgery, 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
- 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
- •The subjects volunteer to sign the informed consent;
- •Aged: 18 to 75 years old;
- •Colorectal cancer (AJCC-TNM, Stage Ⅰ, low-risk Stage Ⅱand Stage Ⅲ; Patients with Stage Ⅲ colorectal cancer refuse to postoperative adjuvant chemotherapy);
- •The diagnosis and colorectal cancer has been confirmed by pathological examination after radical surgery;
- •The liver and kidney function satisfies the following conditions within 15 days after surgery (excluding day 15): aspartate aminotransferase (AST), glutamic-oxalacetic transaminase (ALT), alkaline phosphatase (ALP)< 2 upper limit of normal (ULN), total bilirubin ≤ 1.5 ULN, serum creatinine < 1.5 ULN; normal coagulation function;
- •Other laboratory tests meet the following requirements within 15 days after surgery (excluding day 15): white blood cells count ≥ 3.0×109/L, absolute neutrophil count ≥ 1.5×109/L, platelet count ≥ 100×109/L;
- •ECOG：0-2 points；
- •No other previous history of malignancy.
排除标准
- •Multiple primary cancer;
- •Not recover from the colorectal surgery;
- •Presence of organ, bone, or skin metastases;
- •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
Experimental
Huaier Granule will be administrated from 4 to 48 weeks after surgery or until study termination. Huaier Granule is continuously taken three times per day, 20g per time.
干预措施: Huaier Granule (Drug)
结局指标
主要结局
Disease-free survival (DFS)
时间窗: 1 year
DFS was defined as the date of definitive surgery until the date of recurrence, metastasis, appearance of a second primary tumor, or death from any cause, whichever occurs first.
次要结局
- Overall survival (OS)(5 years)
- Relapse-free survival (RFS)(5 years)
- Metastasis-free survival (MFS)(5 years)
研究者
Xiaojian Wu
Prof.
Sixth Affiliated Hospital, Sun Yat-sen University
研究点 (1)
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