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.
Study Type
OBSERVATIONAL
Enrollment
3,060
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Disease-Free Survival(DFS)
Disease free survival (DFS) was defined as the time from participation to the time of tumor recurrence or death.
Time frame: 36 months
Overall survival(OS)
OS was defined as the time from participation to death from any cause or last patient last visit.
Time frame: 36 months
Local recurrence-Free Survival rate
The proportion of Local recurrence-Free Survival subjects to the total number of subjects.
Time frame: 36 months
Distant Metastasis-Free Survival rate
The proportion of Distant Metastasis-Free Surviva subjects to the total number of subjects.
Time frame: 36 months
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.
Time frame: 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.
Time frame: 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.
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The First Clinical Hospital affiliated to Harbin Medical University
Harbin, Heilongjiang, China
RECRUITINGThe Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
RECRUITINGHubei Cancer Hospita
Wuhan, Hubei, China
RECRUITINGUnion Hospital Tongji College Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGHunan Provincial People's Hospital
Changsha, Hunan, China
RECRUITINGXiangya Hospital Central South University
Changsha, Hunan, China
RECRUITINGChangzhou No.2 People's Hospital
Changzhou, Jiangsu, China
RECRUITINGThe Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
RECRUITINGNorthern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
RECRUITING...and 12 more locations
Time frame: 36 months
Immunity function
Immunity function was measured with Immune cells counts and positive rate.
Time frame: 36 months