Huaier Granules for Prevention of Recurrence and Metastasis of Colorectal Cancer Patients Following Radical Surgery

NCT ID: NCT03349762

Last Updated: 2024-06-03

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

RECRUITING

Total Enrollment

3060 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-02

Study Completion Date

2028-06-30

Brief Summary

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To evaluate the efficacy and safety of Huaier granules for Prevention of Recurrence and Metastasis of colorectal cancer patients following radical surgery

Detailed Description

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This is a multisite, open-label, prospective study investigating Huaier Granule for Prevention of Recurrence and Metastasis of colorectal cancer patients following radical surgery,to evaluate the efficacy and safety.

Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational 1

Radiotherapy or Chemotherapy

No interventions assigned to this group

Observational 2

Huaier Granule \& Radiotherapy or chemotherapy

No interventions assigned to this group

Observational 3

Huaier Granules

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Males or females ages 18-75 years;
2. The first time to the therapy of patients who received the radical surgery within two months, Postoperative histopathology confirms the diagnosis of colorectal cancer with stage IIB, IIC and III ( TNM classification)
3. ECOG score of 0-2;
4. No history of malignant tumors;
5. The patients are volunteered for the study, sign informed consent form and cooperate with Investigator to collect data.

Exclusion Criteria

1. Patients have basic diseases including heart diseases, cerebrovascular disease, lung disease, severe hypertension or diabetes with poor glycemic control;
2. confirmed infections after surgery ;
3. Patients who have post-surgery complications or who are currently under the influence of the radical surgery for colorectal cancer;
4. Being infected with syphilis or with other blood-borne infectious diseases;
5. Pregnancy or lactation; or women of childbearing potential not using contraception;
6. Patients who have taken Traditional Chinese Medicines with efficacy and indications similar to that of Huaier granule - including, but not limited to, compound Banmao capsule., Huachansu capsule, Kangai Injection and Pingxiao tablets;
7. Patients who are suffering from mental illness or Conditions that are considered not suitable for this study investigators.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xi Shan Wang

OTHER

Sponsor Role lead

Responsible Party

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Xi Shan Wang

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Xishan Wang, Professor

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

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The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status RECRUITING

The First Clinical Hospital affiliated to Harbin Medical University

Harbin, Heilongjiang, China

Site Status RECRUITING

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status RECRUITING

Hubei Cancer Hospita

Wuhan, Hubei, China

Site Status RECRUITING

Union Hospital Tongji College Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status RECRUITING

Hunan Provincial People's Hospital

Changsha, Hunan, China

Site Status RECRUITING

Xiangya Hospital Central South University

Changsha, Hunan, China

Site Status RECRUITING

Changzhou No.2 People's Hospital

Changzhou, Jiangsu, China

Site Status RECRUITING

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Site Status RECRUITING

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China

Site Status RECRUITING

Anshan Cancer Hospital

Anshan, Liaoning, China

Site Status RECRUITING

Ansteel Group General Hospital

Anshan, Liaoning, China

Site Status RECRUITING

The First Affiliated Hospital of Jinzhou Medical University

Jinzhou, Liaoning, China

Site Status RECRUITING

Shandong Provincial Hospital

Jinan, Shandong, China

Site Status RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Site Status RECRUITING

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Site Status RECRUITING

Zaozhuang Municipal Hospital

Zaozhuang, Shandong, China

Site Status RECRUITING

First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

Site Status RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Site Status RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, , China

Site Status RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xishan Wang, Professor

Role: CONTACT

+0086-13552367779

Facility Contacts

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Guiying Wang

Role: primary

Daxun Piao

Role: primary

Guiyu Wang

Role: primary

Shaozhong Wei

Role: primary

Kaixiong Tao

Role: primary

Zhongcheng Huang

Role: primary

Zihua Chen

Role: primary

Liming Tang

Role: primary

Jun Song

Role: primary

Rongdao Wang

Role: primary

Yuyang Dong

Role: primary

Dengbin Wu

Role: primary

Hang Lu

Role: primary

Leping Li

Role: primary

Yun Lu

Role: primary

Zhongchuan Lv

Role: primary

Junling Hou

Role: primary

Chengxue Dang

Role: primary

dalu kong, professor

Role: primary

1862221078

Wenbin Zhang

Role: primary

Xishan Wang

Role: primary

Xinxiang Li

Role: primary

Other Identifiers

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HE-201709

Identifier Type: -

Identifier Source: org_study_id

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