Evaluation for NCI Surgery Branch Clinical Research Protocols
NCT00001823
Bladder Cancer, Colonic Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT Number: NCT03349762
To evaluate the efficacy and safety of Huaier granules for Prevention of Recurrence and Metastasis of colorectal cancer patients following radical surgery
Interested in participating?
Request Info18 year–75 year
All sexes
Observational
The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 36 months
Disease free survival (DFS) was defined as the time from participation to the time of tumor recurrence or death.
Time frame: 36 months
OS was defined as the time from participation to death from any cause or last patient last visit.
Time frame: 36 months
The proportion of Local recurrence-Free Survival subjects to the total number of subjects.
Time frame: 36 months
The proportion of Distant Metastasis-Free Surviva subjects to the total number of subjects.
Time frame: 36 months
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
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
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.
Time frame: 36 months
Immunity function was measured with Immune cells counts and positive rate.
Contact information is provided by the study sponsor or research team.
Xi Shan Wang
Other
A Real-World Study Investigating Huaier Granules for Prevention of Recurrence and Metastasis of Colorectal Cancer Patients Following Radical Surgery
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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