Colorectal CancerNCT03349762
Huaier Granules for Prevention of Recurrence and Metastasis of Colorectal Cancer Patients Following Radical Surgery
An observational study of Colorectal Cancer, run by Xi Shan Wang at 22 sites in China.
Trial summary
To evaluate the efficacy and safety of Huaier granules for Prevention of Recurrence and Metastasis of colorectal cancer patients following radical surgery Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- How many people
- 3,060 participants
- Where
- 22 sitesChina
- Study dates
- 2 Nov 2018to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Colorectal cancer patients after radical surgery
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
China22 sites, 22 recruiting
- Recruiting
Anshan Cancer Hospital
Anshan, Liaoning
Yuyang Dong
- Recruiting
Ansteel Group General Hospital
Anshan, Liaoning
Dengbin Wu
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Xishan Wang
- Recruiting
Hunan Provincial People's Hospital
Changsha, Hunan
Zhongcheng Huang
- Recruiting
Xiangya Hospital Central South University
Changsha, Hunan
Zihua Chen
- Recruiting
Changzhou No.2 People's Hospital
Changzhou, Jiangsu
Liming Tang
- Recruiting
The First Clinical Hospital affiliated to Harbin Medical University
Harbin, Heilongjiang
Daxun Piao
- Recruiting
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Guiyu Wang
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong
Leping Li
- Recruiting
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning
Hang Lu
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
Yun Lu
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Xinxiang Li
- Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei
Guiying Wang
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality
dalu kong, professor, 1862221078, kongdl@hotmail.com
- Recruiting
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
Wenbin Zhang
- Recruiting
Hubei Cancer Hospita
Wuhan, Hubei
Shaozhong Wei
- Recruiting
Union Hospital Tongji College Huazhong University of Science and Technology
Wuhan, Hubei
Kaixiong Tao
- Recruiting
First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi
Chengxue Dang
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
Jun Song
- Recruiting
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu
Rongdao Wang
- Recruiting
Yantai Yuhuangding Hospital
Yantai, Shandong
Zhongchuan Lv
- Recruiting
Zaozhuang Municipal Hospital
Zaozhuang, Shandong
Junling Hou
About this study
Official title: A Real-World Study Investigating Huaier Granules for Prevention of Recurrence and Metastasis of Colorectal Cancer Patients Following Radical Surgery
To evaluate the efficacy and safety of Huaier granules for Prevention of Recurrence and Metastasis of colorectal cancer patients following radical surgery
Read the detailed description
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
- Colorectal Cancer
- Keywords
- Huaier Granule, multisite, open-label, prospective
- Medical subject headings
- Colorectal 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 | Radiotherapy or Chemotherapy | |
| Observational 2 | Huaier Granule \& Radiotherapy or chemotherapy | |
| Observational 3 | Huaier Granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free Survival(DFS)
Disease free survival (DFS) was defined as the time from participation to the time of tumor recurrence or death.
Measured: 36 months
Overall survival(OS)
OS was defined as the time from participation to death from any cause or last patient last visit.
Measured: 36 months
Local recurrence-Free Survival rate
The proportion of Local recurrence-Free Survival subjects to the total number of subjects.
Measured: 36 months
Distant Metastasis-Free Survival rate
The proportion of Distant Metastasis-Free Surviva subjects to the total number of subjects.
Measured: 36 months
Secondary outcomes (4)
Change From Baseline in Quality of Life (QOL)
Quality of Life (QOL) were measured using supplemental quality of life questions. Item score range（12 items）: 1 (worst symptom) to 5 (no symptom). Change: score at 36 months minus score at baseline.
Measured: 36 months
Incidence rate of Adverse events (AE)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Measured: 36 months
Severity of Adverse events
An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: 36 months
Immunity function
Immunity function was measured with Immune cells counts and positive rate.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start2 Nov 2018
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,060 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xi Shan Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xi Shan Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Xishan Wang, Professor, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03349762
- Sponsor's protocol ID
- HE-201709
- Status last verified
- May 2024
- First submitted
- 14 Nov 2017
- Last updated
- 3 Jun 2024
- 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 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Study Investigating Huaier Granules for Prevention of Recurrence and Metastasis of Colorectal Cancer Patients Following Radical Surgery
- ClinicalTrials.gov ID
- NCT03349762
- Acronym / sponsor ID
- HE-201709
- Conditions
- Colorectal Cancer
- Keywords
- Huaier Granule, multisite, open-label, prospective
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,060 participants (estimated)
- Lead sponsor
- Xi Shan WangUniversity, hospital or other
- Study start
- 2 Nov 2018 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 22 Nov 2017 (actual)
- 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.
To evaluate the efficacy and safety of Huaier granules for Prevention of Recurrence and Metastasis of colorectal cancer patients following radical surgery
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Observational 1 | – | –Radiotherapy or Chemotherapy |
| Observational 2 | – | –Huaier Granule \& Radiotherapy or chemotherapy |
| Observational 3 | – | –Huaier Granules |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Colorectal cancer patients after radical surgery
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
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: 36 months
Disease free survival (DFS) was defined as the time from participation to the time of tumor recurrence or death.
Overall survival(OS)
Time frame: 36 months
OS was defined as the time from participation to death from any cause or last patient last visit.
Local recurrence-Free Survival rate
Time frame: 36 months
The proportion of Local recurrence-Free Survival subjects to the total number of subjects.
Distant Metastasis-Free Survival rate
Time frame: 36 months
The proportion of Distant Metastasis-Free Surviva subjects to the total number of subjects.
4 secondary outcomes
Change From Baseline in Quality of Life (QOL)
Time frame: 36 months
Incidence rate of Adverse events (AE)
Time frame: 36 months
Severity of Adverse events
Time frame: 36 months
Immunity function
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
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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.
Xishan Wang, Professor principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Xi Shan Wang at 22 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xishan Wang, Professor (+0086-13552367779, wangxishanzy@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-Free Survival(DFS) (time frame: 36 months). The study lists 4 primary outcomes in all. 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 3 Jun 2024.