Registry of Huaier Granule for Prevention of Recurrence and Metastasis of Gastrointestinal Cancer After Radical Surgery
1 other identifier
observational
740
1 country
12
Brief Summary
Registration of patients after gastrointestinal cancer radical surgery, including the information of treatments, recurrence \& metastasis, adverse events,etc.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2017
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2016
CompletedFirst Posted
Study publicly available on registry
November 29, 2016
CompletedStudy Start
First participant enrolled
February 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2024
CompletedOctober 25, 2023
October 1, 2023
6.7 years
November 24, 2016
October 23, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Disease free survival (DFS)
Time from enrollment to tumor recurrence or death with any cause
Up to 2 years
Secondary Outcomes (4)
Disease situation
Baseline period
Quality of Life Score
Up to 2 years
Postoperative treatment methods
Up to 2 years
Concomitant medication
Up to 2 years
Study Arms (4)
Observational 1
Huaier Granule
Observational 2
Radiotherapy or chemotherapy
Observational 3
treatment abandoned
Observational 4
Huaier Granule \& Radiotherapy or chemotherapy
Eligibility Criteria
Patients after gastrointestinal cancer radical surgery.
You may qualify if:
- Patients with gastrointestinal cancer (stomach, colon or rectum);
- Patients who have received gastrointestinal cancer radical surgery within a month;
- Patients between 18 and 70 years old,no gender restriction;
- Patients volunteer to participate this study and have signed the informed consent form.
You may not qualify if:
- No chemotherapy or combined radiation and chemotherapy indicationsï¼›
- Unable to cooperate to complete related information collection;
- Participation in any other clinical trial within three months;
- Conditions that are considered not suitable for this study investigators.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150086, China
The First Affiliated Hospital of Qiqihar Medical College
Qiqihar, Heilongjiang, 161005, China
Hulunbuir People's Hospital
Hailar, Inner Mongolia, 021008, China
Nanjing First Hospital
Nanjing, Jiangsu, 210012, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001, China
The Second Hospital of Jilin University
Changchun, Jilin, 130041, China
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, 116001, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011, China
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, 121012, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110002, China
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, 030012, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tongjun Liu, PhD
Second Hospital of Jilin University
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2016
First Posted
November 29, 2016
Study Start
February 4, 2017
Primary Completion
October 20, 2023
Study Completion
February 1, 2024
Last Updated
October 25, 2023
Record last verified: 2023-10