Gastrointestinal Cancer
Conditions
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.
Interventions
None listed
Sponsors
Second Hospital of Jilin University
Huazhong University of Science and Technology
Qidong Gaitianli Medicines Co., Ltd
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with gastrointestinal cancer (stomach, colon or rectum); 2. Patients who have received gastrointestinal cancer radical surgery within a month; 3. Patients between 18 and 70 years old,no gender restriction; 4. Patients volunteer to participate this study and have signed the informed consent form.
Exclusion criteria
1. No chemotherapy or combined radiation and chemotherapy indications； 2. Unable to cooperate to complete related information collection; 3. Participation in any other clinical trial within three months; 4. Conditions that are considered not suitable for this study investigators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival (DFS) | Up to 2 years | Time from enrollment to tumor recurrence or death with any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease situation | Baseline period | Generally refers to tumor staging, classification, surgical methods, etc |
| 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. |
| 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. |
Countries
China
Outcome results
None listed