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

Gastrointestinal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02975661
• Other study ID #: HE-201601
• Status: Active, not recruiting
• Start date: February 4, 2017
• Est. completion date: February 2024

Study information

• Verified date: October 2023
• Source: Qidong Gaitianli Medicines Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 740
• Est. completion date: February 2024
• Est. primary completion date: October 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Recurrence

Locations

Country	Name	City	State
China	The Second Hospital of Jilin University	Changchun	Jilin
China	Affiliated Zhongshan Hospital of Dalian University	Dalian	Liaoning
China	The First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning
China	Hulunbuir People's Hospital	Hailar	Inner Mongolia
China	The Second Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The First Affiliated Hospital of Jinzhou Medical University	Jinzhou	Liaoning
China	Nanjing First Hospital	Nanjing	Jiangsu
China	The First Affiliated Hospital of Qiqihar Medical College	Qiqihar	Heilongjiang
China	The First Affiliated Hospital of China Medical University	Shenyang	Liaoning
China	Shanxi Bethune Hospital	Taiyuan	Shanxi
China	Shanxi Provincial People's Hospital	Taiyuan	Shanxi
China	Northern Jiangsu People's Hospital	Yangzhou	Jiangsu

Sponsors (3)

Lead Sponsor	Collaborator
Qidong Gaitianli Medicines Co., Ltd	Huazhong University of Science and Technology, Second Hospital of Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival (DFS)	Time from enrollment to tumor recurrence or death with any cause	Up to 2 years
Secondary	Disease situation	Generally refers to tumor staging, classification, surgical methods, etc	Baseline period
Secondary	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
Secondary	Postoperative treatment methods	Generally including treatment plan, compliance, etc	Up to 2 years
Secondary	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