To evaluate the efficacy and safety of Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma following Local Ablation
A multicenter, prospective cohort study investigating Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma following Local Ablation,to evaluate the efficacy and safety
Study Type
OBSERVATIONAL
Enrollment
828
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGProgression-free survival (PFS)
PFS was defined as the duration of time from start of treatment to time of disease progression.
Time frame: 96 weeks
Recurrence-Free Survival (RFS)
RFS was defined as the duration of time from start of treatment to time of disease recurrence .
Time frame: 96 weeks
Time to recurrence (TTR)
TTR was defined as the time from shart of treatment to disease recurrence.
Time frame: Time from baseline to relapse (up to 96 weeks)
Overall Survival (OS)
OS was defined as the time from start to death from any cause or last patient last visit.
Time frame: Time from baseline to death (up to 96 weeks)
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 96 weeks minus score at baseline.
Time frame: 24, 48, 72, 96 weeks
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: 96 weeks
severity of Adverse events (AE)
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.
Han
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Shijiazhuang Fifth Hospital
Shijiazhuang, Hebei, China
RECRUITINGAffiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, China
RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGUnion Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGThe Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, China
RECRUITINGThe Second Hospital of Dalian Medical University
Dalian, Liaoning, China
RECRUITINGShandong Provincial Hospital
Jinan, Shandong, China
RECRUITINGThe Second Hospital of Shandong University
Jinan, Shandong, China
RECRUITINGThe Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
RECRUITING...and 7 more locations
Time frame: 96 weeks