Gastrointestinal CancerNCT02975661
Registry of Huaier Granule for Prevention of Recurrence and Metastasis of Gastrointestinal Cancer After Radical Surgery
An observational study of Gastrointestinal Cancer, run by Qidong Gaitianli Medicines Co., Ltd at 12 sites in China.
Trial summary
Registration of patients after gastrointestinal cancer radical surgery, including the information of treatments, recurrence \& metastasis, adverse events,etc. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastrointestinal Cancer
- How many people
- 740 participants
- Where
- 12 sitesChina
- Study dates
- 4 Feb 2017to Feb 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients after gastrointestinal cancer radical surgery.
Who may be able to join
- 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.
Who cannot join
- No chemotherapy or combined radiation and chemotherapy indications；
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
The Second Hospital of Jilin University
Changchun, Jilin, 130041
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, 116001
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011
Hulunbuir People's Hospital
Hailar, Inner Mongolia, 021008
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150086
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, 121012
Nanjing First Hospital
Nanjing, Jiangsu, 210012
The First Affiliated Hospital of Qiqihar Medical College
Qiqihar, Heilongjiang, 161005
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110002
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, 030012
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001
About this study
Registration of patients after gastrointestinal cancer radical surgery, including the information of treatments, recurrence \& metastasis, adverse events,etc.
Read the detailed 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.
- Conditions
- Gastrointestinal Cancer
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational 1 | Huaier Granule | |
| Observational 2 | Radiotherapy or chemotherapy | |
| Observational 3 | treatment abandoned | |
| Observational 4 | Huaier Granule \& Radiotherapy or chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival (DFS)
Time from enrollment to tumor recurrence or death with any cause
Measured: Up to 2 years
Secondary outcomes (4)
Disease situation
Generally refers to tumor staging, classification, surgical methods, etc
Measured: Baseline period
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.
Measured: Up to 2 years
Postoperative treatment methods
Generally including treatment plan, compliance, etc
Measured: Up to 2 years
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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study start4 Feb 2017
- Primary completion20 Oct 2023
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 740 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Qidong Gaitianli Medicines Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Second Hospital of Jilin University, Huazhong University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Tongjun Liu, PhD, Principal investigator, Second Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975661
- Sponsor's protocol ID
- HE-201601
- Status last verified
- Oct 2023
- First submitted
- 24 Nov 2016
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Huaier Granule for Prevention of Recurrence and Metastasis of Gastrointestinal Cancer After Radical Surgery
- ClinicalTrials.gov ID
- NCT02975661
- Acronym / sponsor ID
- HE-201601
- Conditions
- Gastrointestinal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 740 participants (actual)
- Lead sponsor
- Qidong Gaitianli Medicines Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Second Hospital of Jilin University, Huazhong University of Science and Technology
- Study start
- 4 Feb 2017 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- Feb 2024 (estimated)
- First posted
- 29 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Registration of patients after gastrointestinal cancer radical surgery, including the information of treatments, recurrence \& metastasis, adverse events,etc.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Observational 1 | – | –Huaier Granule |
| Observational 2 | – | –Radiotherapy or chemotherapy |
| Observational 3 | – | –treatment abandoned |
| Observational 4 | – | –Huaier Granule \& Radiotherapy or chemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after gastrointestinal cancer radical surgery.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- No chemotherapy or combined radiation and chemotherapy indications；
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease free survival (DFS)
Time frame: Up to 2 years
Time from enrollment to tumor recurrence or death with any cause
4 secondary outcomes
Disease situation
Time frame: Baseline period
Quality of Life Score
Time frame: Up to 2 years
Postoperative treatment methods
Time frame: Up to 2 years
Concomitant medication
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tongjun Liu, PhD principal investigator
Second Hospital of Jilin University
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Cancer, run by Qidong Gaitianli Medicines Co., Ltd at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (DFS) (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.