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

Qidong Gaitianli Medicines Co., Ltd740 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

740

Conditions

Gastrointestinal Cancer

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (12)

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

The First Affiliated Hospital of Qiqihar Medical College

Qiqihar, Heilongjiang, China

Hulunbuir People's Hospital

Hailar, Inner Mongolia, China

Outcomes

Primary Outcomes

Disease free survival (DFS)

Time from enrollment to tumor recurrence or death with any cause

Time frame: Up to 2 years

Secondary Outcomes

Disease situation

Generally refers to tumor staging, classification, surgical methods, etc

Time frame: 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.

Time frame: Up to 2 years

Postoperative treatment methods

Generally including treatment plan, compliance, etc

Time frame: 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.

Time frame: Up to 2 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.