NCT02975661进行中（未招募）不适用
Registry of Huaier Granule for Prevention of Recurrence and Metastasis of Gastrointestinal Cancer After Radical Surgery
Qidong Gaitianli Medicines Co., Ltd12 个研究点 分布在 1 个国家目标入组 740 人开始时间: 2017年2月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 740
- 试验地点
- 12
- 主要终点
- Disease free survival (DFS)
研究概览
简要总结
Registration of patients after gastrointestinal cancer radical surgery, including the information of treatments, recurrence & metastasis, adverse events,etc.
详细描述
This study adopts a multicenter, open, and registered research method, and plans to include 840 cases, including 360 cases in the Huaier Granule test group, 360 cases in the radiotherapy and chemotherapy control group, and 120 cases in the blank group. Using natural grouping, the registered objects are not pre grouped or queue divided, and the diagnosis, treatment, efficacy, and safety of gastrointestinal malignant tumor patients are accurately recorded under real conditions.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with gastrointestinal cancer (stomach, colon or rectum);
- •Patients who have received gastrointestinal cancer radical surgery within a month;
- •Patients between 18 and 70 years old,no gender restriction;
- •Patients volunteer to participate this study and have signed the informed consent form.
排除标准
- •No chemotherapy or combined radiation and chemotherapy indications；
- •Unable to cooperate to complete related information collection;
- •Participation in any other clinical trial within three months;
- •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: Up to 2 years
Time from enrollment to tumor recurrence or death with any cause
次要结局
- Disease situation(Baseline period)
- Postoperative treatment methods(Up to 2 years)
- Concomitant medication(Up to 2 years)
- Quality of Life Score(Up to 2 years)
研究者
研究点 (12)
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