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

NCT ID: NCT02975661

Last Updated: 2023-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

740 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-04

Study Completion Date

2024-02-29

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.

Conditions

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Gastrointestinal Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational 1

Huaier Granule

No interventions assigned to this group

Observational 2

Radiotherapy or chemotherapy

No interventions assigned to this group

Observational 3

treatment abandoned

No interventions assigned to this group

Observational 4

Huaier Granule \& Radiotherapy or chemotherapy

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Hospital of Jilin University

OTHER

Sponsor Role collaborator

Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

Qidong Gaitianli Medicines Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tongjun Liu, PhD

Role: PRINCIPAL_INVESTIGATOR

Second Hospital of Jilin University

Locations

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The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status

The First Affiliated Hospital of Qiqihar Medical College

Qiqihar, Heilongjiang, China

Site Status

Hulunbuir People's Hospital

Hailar, Inner Mongolia, China

Site Status

Nanjing First Hospital

Nanjing, Jiangsu, China

Site Status

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China

Site Status

The Second Hospital of Jilin University

Changchun, Jilin, China

Site Status

Affiliated Zhongshan Hospital of Dalian University

Dalian, Liaoning, China

Site Status

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Site Status

The First Affiliated Hospital of Jinzhou Medical University

Jinzhou, Liaoning, China

Site Status

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Site Status

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, China

Site Status

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Site Status

Countries

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China

Other Identifiers

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HE-201601

Identifier Type: -

Identifier Source: org_study_id

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