Registry of Huaier Granule for Prevention of Recurrence and Metastasis of Gastrointestinal Cancer After Radical Surgery
- Conditions
- Gastrointestinal Cancer
- Registration Number
- NCT02975661
- Lead Sponsor
- Qidong Gaitianli Medicines Co., Ltd
- Brief Summary
Registration of patients after gastrointestinal cancer radical surgery, including the information of treatments, recurrence \& metastasis, adverse events,etc.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 740
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease free survival (DFS) Up to 2 years Time from enrollment to tumor recurrence or death with any cause
- Secondary Outcome Measures
Name Time Method Postoperative treatment methods Up to 2 years Generally including treatment plan, compliance, etc
Concomitant medication Up to 2 years Other drugs (including chemical drugs, biological products, traditional Chinese patent medicines and simple preparations) taken by the subject in addition to the conventional research drugs during the clinical trial.
Quality of Life Score Up to 2 years Evaluate the quality of life of subjects during the trial by using the SF-36 scale.Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
Disease situation Baseline period Generally refers to tumor staging, classification, surgical methods, etc
Trial Locations
- Locations (12)
The Second Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Hulunbuir People's Hospital
🇨🇳Hailar, Inner Mongolia, China
The First Affiliated Hospital of Qiqihar Medical College
🇨🇳Qiqihar, Heilongjiang, China
The Second Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
Nanjing First Hospital
🇨🇳Nanjing, Jiangsu, China
Northern Jiangsu People's Hospital
🇨🇳Yangzhou, Jiangsu, China
The First Affiliated Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Affiliated Zhongshan Hospital of Dalian University
🇨🇳Dalian, Liaoning, China
The First Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
Shanxi Provincial People's Hospital
🇨🇳Taiyuan, Shanxi, China
The First Affiliated Hospital of Jinzhou Medical University
🇨🇳Jinzhou, Liaoning, China
Shanxi Bethune Hospital
🇨🇳Taiyuan, Shanxi, China