A Real-World Study Investigating Huaier Granules for Prevention of Recurrence and Metastasis of Colorectal Cancer Patients Following Radical Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,060
- 试验地点
- 22
- 主要终点
- Disease-Free Survival(DFS)
研究概览
简要总结
To evaluate the efficacy and safety of Huaier granules for Prevention of Recurrence and Metastasis of colorectal cancer patients following radical surgery
详细描述
This is a multisite, open-label, prospective study investigating Huaier Granule for Prevention of Recurrence and Metastasis of colorectal cancer patients following radical surgery，to evaluate the efficacy and safety.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Males or females ages 18-75 years;
- •The first time to the therapy of patients who received the radical surgery within two months, Postoperative histopathology confirms the diagnosis of colorectal cancer with stage IIB, IIC and III ( TNM classification)
- •ECOG score of 0-2;
- •No history of malignant tumors;
- •The patients are volunteered for the study, sign informed consent form and cooperate with Investigator to collect data.
排除标准
- •Patients have basic diseases including heart diseases, cerebrovascular disease, lung disease, severe hypertension or diabetes with poor glycemic control;
- •confirmed infections after surgery ;
- •Patients who have post-surgery complications or who are currently under the influence of the radical surgery for colorectal cancer;
- •Being infected with syphilis or with other blood-borne infectious diseases;
- •Pregnancy or lactation; or women of childbearing potential not using contraception;
- •Patients who have taken Traditional Chinese Medicines with efficacy and indications similar to that of Huaier granule - including, but not limited to, compound Banmao capsule., Huachansu capsule, Kangai Injection and Pingxiao tablets;
- •Patients who are suffering from mental illness or Conditions that are considered not suitable for this study investigators.
结局指标
主要结局
Disease-Free Survival(DFS)
时间窗: 36 months
Disease free survival (DFS) was defined as the time from participation to the time of tumor recurrence or death.
Overall survival(OS)
时间窗: 36 months
OS was defined as the time from participation to death from any cause or last patient last visit.
Local recurrence-Free Survival rate
时间窗: 36 months
The proportion of Local recurrence-Free Survival subjects to the total number of subjects.
Distant Metastasis-Free Survival rate
时间窗: 36 months
The proportion of Distant Metastasis-Free Surviva subjects to the total number of subjects.
次要结局
- Change From Baseline in Quality of Life (QOL)(36 months)
- Severity of Adverse events(36 months)
- Immunity function(36 months)
- Incidence rate of Adverse events (AE)(36 months)
研究者
Xi Shan Wang
Professor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences