Huaier Granules for Prevention of Recurrence and Metastasis of Colorectal Cancer Patients Following Radical Surgery
A Real-World Study Investigating Huaier Granules for Prevention of Recurrence and Metastasis of Colorectal Cancer Patients Following Radical Surgery
1 other identifier
observational
3,060
1 country
22
Brief Summary
To evaluate the efficacy and safety of Huaier granules for Prevention of Recurrence and Metastasis of colorectal cancer patients following radical surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2018
Longer than P75 for all trials
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2017
CompletedFirst Posted
Study publicly available on registry
November 22, 2017
CompletedStudy Start
First participant enrolled
November 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
June 3, 2024
May 1, 2024
9.2 years
November 14, 2017
May 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Disease-Free Survival(DFS)
Disease free survival (DFS) was defined as the time from participation to the time of tumor recurrence or death.
36 months
Overall survival(OS)
OS was defined as the time from participation to death from any cause or last patient last visit.
36 months
Local recurrence-Free Survival rate
The proportion of Local recurrence-Free Survival subjects to the total number of subjects.
36 months
Distant Metastasis-Free Survival rate
The proportion of Distant Metastasis-Free Surviva subjects to the total number of subjects.
36 months
Secondary Outcomes (4)
Change From Baseline in Quality of Life (QOL)
36 months
Incidence rate of Adverse events (AE)
36 months
Severity of Adverse events
36 months
Immunity function
36 months
Study Arms (3)
Observational 1
Radiotherapy or Chemotherapy
Observational 2
Huaier Granule \& Radiotherapy or chemotherapy
Observational 3
Huaier Granules
Eligibility Criteria
Colorectal cancer patients after radical surgery
You may qualify if:
- Males or females ages 18-75 years;
- 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)
- ECOG score of 0-2;
- No history of malignant tumors;
- The patients are volunteered for the study, sign informed consent form and cooperate with Investigator to collect data.
You may not qualify if:
- Patients have basic diseases including heart diseases, cerebrovascular disease, lung disease, severe hypertension or diabetes with poor glycemic control;
- confirmed infections after surgery ;
- Patients who have post-surgery complications or who are currently under the influence of the radical surgery for colorectal cancer;
- Being infected with syphilis or with other blood-borne infectious diseases;
- Pregnancy or lactation; or women of childbearing potential not using contraception;
- 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;
- Patients who are suffering from mental illness or Conditions that are considered not suitable for this study investigators.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xi Shan Wanglead
Study Sites (22)
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The First Clinical Hospital affiliated to Harbin Medical University
Harbin, Heilongjiang, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Hubei Cancer Hospita
Wuhan, Hubei, China
Union Hospital Tongji College Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Changzhou No.2 People's Hospital
Changzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
Anshan Cancer Hospital
Anshan, Liaoning, China
Ansteel Group General Hospital
Anshan, Liaoning, China
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, China
Shandong Provincial Hospital
Jinan, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Zaozhuang Municipal Hospital
Zaozhuang, Shandong, China
First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Fudan University Shanghai Cancer Center
Shanghai, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xishan Wang, Professor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 14, 2017
First Posted
November 22, 2017
Study Start
November 2, 2018
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
June 30, 2028
Last Updated
June 3, 2024
Record last verified: 2024-05