Adjuvant Chemotherapy Combined With Huaier Granule for Treating High-risk Stage II, Stage III Colorectal Cancer
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, high-risk Stage II and Stage III)
- •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
mFOLFOX6 + Huaier Granule
Twelve cycles of mFOLFOX6 (oxaliplatin, 85 mg/m²; calcium folinate, 400 mg/m²; 5-fluorouracil, 2800 mg/m²). Patients will be treated with chemotherapy every 2 weeks (+/- 2 days ). Huaier Granule will be administrated from the first cycle of chemotherapy until 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)
mFOLFOX6 + Huaier Granule
Twelve cycles of mFOLFOX6 (oxaliplatin, 85 mg/m²; calcium folinate, 400 mg/m²; 5-fluorouracil, 2800 mg/m²). Patients will be treated with chemotherapy every 2 weeks (+/- 2 days ). Huaier Granule will be administrated from the first cycle of chemotherapy until 48 weeks after surgery or until study termination. Huaier Granule is continuously taken three times per day, 20g per time.
干预措施: Oxaliplatin (Drug)
mFOLFOX6 + Huaier Granule
Twelve cycles of mFOLFOX6 (oxaliplatin, 85 mg/m²; calcium folinate, 400 mg/m²; 5-fluorouracil, 2800 mg/m²). Patients will be treated with chemotherapy every 2 weeks (+/- 2 days ). Huaier Granule will be administrated from the first cycle of chemotherapy until 48 weeks after surgery or until study termination. Huaier Granule is continuously taken three times per day, 20g per time.
干预措施: Calcium folinate (Drug)
mFOLFOX6 + Huaier Granule
Twelve cycles of mFOLFOX6 (oxaliplatin, 85 mg/m²; calcium folinate, 400 mg/m²; 5-fluorouracil, 2800 mg/m²). Patients will be treated with chemotherapy every 2 weeks (+/- 2 days ). Huaier Granule will be administrated from the first cycle of chemotherapy until 48 weeks after surgery or until study termination. Huaier Granule is continuously taken three times per day, 20g per time.
干预措施: 5-fluorouracil (Drug)
mFOLFOX6
Twelve cycles of mFOLFOX6 (oxaliplatin, 85 mg/m²; calcium folinate, 400 mg/m²; 5-fluorouracil, 2800 mg/m²). Patients will be treated with chemotherapy every 2 weeks (+/- 2 days ).
干预措施: Oxaliplatin (Drug)
mFOLFOX6
Twelve cycles of mFOLFOX6 (oxaliplatin, 85 mg/m²; calcium folinate, 400 mg/m²; 5-fluorouracil, 2800 mg/m²). Patients will be treated with chemotherapy every 2 weeks (+/- 2 days ).
干预措施: Calcium folinate (Drug)
mFOLFOX6
Twelve cycles of mFOLFOX6 (oxaliplatin, 85 mg/m²; calcium folinate, 400 mg/m²; 5-fluorouracil, 2800 mg/m²). Patients will be treated with chemotherapy every 2 weeks (+/- 2 days ).
干预措施: 5-fluorouracil (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
- Relapse-free survival (RFS)(5 years)
- Metastasis-free survival (MFS)(5 years)
- Overall survival (OS)(5 years)
研究者
Xiaojian Wu
Prof.
Sixth Affiliated Hospital, Sun Yat-sen University