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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational 1 | Radiotherapy or Chemotherapy | ||
| Observational 2 | Huaier Granule & Radiotherapy or chemotherapy | ||
| Observational 3 | Huaier Granules |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 36 months |
| Incidence rate of Adverse events (AE) |
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Inclusion Criteria:
Exclusion Criteria:
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Colorectal cancer patients after radical surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xishan Wang, Professor | Contact | +0086-13552367779 | wangxishanzy@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Xishan Wang, Professor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fourth Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | China |
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An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. |
| 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. | 36 months |
| Immunity function | Immunity function was measured with Immune cells counts and positive rate. | 36 months |
| The First Clinical Hospital affiliated to Harbin Medical University | Recruiting | Harbin | Heilongjiang | China |
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| The Second Affiliated Hospital of Harbin Medical University | Recruiting | Harbin | Heilongjiang | China |
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| Hubei Cancer Hospita | Recruiting | Wuhan | Hubei | China |
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| Union Hospital Tongji College Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | China |
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| Hunan Provincial People's Hospital | Recruiting | Changsha | Hunan | China |
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| Xiangya Hospital Central South University | Recruiting | Changsha | Hunan | China |
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| Changzhou No.2 People's Hospital | Recruiting | Changzhou | Jiangsu | China |
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| The Affiliated Hospital of Xuzhou Medical University | Recruiting | Xuzhou | Jiangsu | China |
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| Northern Jiangsu People's Hospital | Recruiting | Yangzhou | Jiangsu | China |
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| Anshan Cancer Hospital | Recruiting | Anshan | Liaoning | China |
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| Ansteel Group General Hospital | Recruiting | Anshan | Liaoning | China |
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| The First Affiliated Hospital of Jinzhou Medical University | Recruiting | Jinzhou | Liaoning | China |
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| Shandong Provincial Hospital | Recruiting | Jinan | Shandong | China |
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| The Affiliated Hospital of Qingdao University | Recruiting | Qingdao | Shandong | China |
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| Yantai Yuhuangding Hospital | Recruiting | Yantai | Shandong | China |
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| Zaozhuang Municipal Hospital | Recruiting | Zaozhuang | Shandong | China |
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| First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi’an | Shanxi | China |
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| Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | Tianjin Municipality | China |
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| First Affiliated Hospital of Xinjiang Medical University | Recruiting | Ürümqi | Xinjiang | China |
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| Cancer Hospital Chinese Academy of Medical Sciences | Recruiting | Beijing | China |
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| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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