Registry of Huaier Granule for Prevention of Recurrence and Metastasis of Gastrointestinal Cancer After Radical Surgery

Study Overview
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Brief Summary
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Registration of patients after gastrointestinal cancer radical surgery, including the information of treatments, recurrence & metastasis, adverse events,etc.

Detailed Description
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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.

Official Title
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Registry of Huaier Granule for Prevention of Recurrence and Metastasis of Gastrointestinal Cancer After Radical Surgery

Conditions
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Gastrointestinal Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational 1<br>Huaier Granule | |
| Observational 2<br>Radiotherapy or chemotherapy | |
| Observational 3<br>treatment abandoned | |
| Observational 4<br>Huaier Granule & Radiotherapy or chemotherapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival (DFS) | Time from enrollment to tumor recurrence or death with any cause | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease situation | Generally refers to tumor staging, classification, surgical methods, etc | Baseline period | 
| Quality of Life Score | 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. | Up to 2 years | 
| Postoperative treatment methods | Generally including treatment plan, compliance, etc | Up to 2 years | 
| Concomitant medication | 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. | Up to 2 years |