Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma Following Local Ablation
- Conditions
- Hepatocarcinoma
- Registration Number
- NCT03356236
- Lead Sponsor
- Yue Han
- Brief Summary
To evaluate the efficacy and safety of Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma following Local Ablation
- Detailed Description
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 828
- 18 years ≤ Age ≤ 75 years, both male and female
- Patients are diagnosed with HCC via examination of tissues according to Guidelines for Diagnosis and Treatment of Hepatocellular Carcinoma (Version 2017) by NHFPC (National Health and Family Planning Commission of the People's Republic of China) and/or HCC imaging criteria of American Association for the Study of Liver Diseases (AASLD) for the diagnosis of HCC;
- Radiographic testing shows cancer cells have been eliminated after four weeks of Local Ablation;Complete Response (CR): Dynamic contrast-enhanced CT scans and follow-up MR images show low-density area of Hepatocellular Carcinoma and no enhancement during the arterial phase of contrast-enhanced CT; also patients with 0.5-1 cm beyond the limits of the tumor margins (considered as safe surgical margins) are eligible;
- According to contrast-enhanced CT and MRI, with solitary tumor smaller than 5 cm in diameter; with multiple tumors (no more than 3 masses), the largest dimension is less than 3 cm;
- Patients are eligible if Hemoglobin (Hb) count ≥90g/L, platelets count (PLT) ≥60×109/L, absolute neutrophil count (ANC) count >1.0×109/L, prothrombin activity (PTA)>50%, serum creatinine is less than 1.5 times ULN (Upper Limit of Normal) and total bilirubin (TBIL) <51.3μmol/L (3 mg/dL);
- ECOG score of 0-1;
- Liver function is Child - Pugh grade A or B.
- History of TACE for treatment of HCC is less than or equal to twice -
- The patients are volunteered for the study, sign informed consent form and cooperate with Investigator to collect data.
- Radiographic testing shows cancer cells have not been eliminated after four weeks of Local Ablation;
- The occurrence of embolism occurs in large blood vessels on liver, patients with extrahepatic metastatic of HCC or liver transplantation;
- Patients who are about to receive or already received chemotherapy or molecular targeted therapy;
- Patients who are about to receive TACE treatment for HCC;
- Patients without previous treatment of Huaier granules.
- History of diabetes;
- HCC patients with uncontrollable ascites at the beginning of enrollment of the study or are very likely to have ascites during the next four weeks at the time of enrollment; patients with hepatic encephalopathy or upper gastrointestinal bleeding;
- Patients have basic diseases including severe cardiopulmonary insufficiency, renal insufficiency, or severe mental illness;
- Patients with other infectious disease (excluding viral hepatitis)
- Patients who cannot take oral medication;
- Conditions that are considered not suitable for this study investigators.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) 96 weeks PFS was defined as the duration of time from start of treatment to time of disease progression.
- Secondary Outcome Measures
Name Time Method Recurrence-Free Survival (RFS) 96 weeks RFS was defined as the duration of time from start of treatment to time of disease recurrence .
Time to recurrence (TTR) Time from baseline to relapse (up to 96 weeks) TTR was defined as the time from shart of treatment to disease recurrence.
severity of Adverse events (AE) 96 weeks 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.
Overall Survival (OS) Time from baseline to death (up to 96 weeks) OS was defined as the time from start to death from any cause or last patient last visit.
Change From Baseline in Quality of Life (QOL) 24, 48, 72, 96 weeks 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.
Incidence rate of Adverse events (AE) 96 weeks An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Trial Locations
- Locations (17)
Chongqing Cancer Hospital
🇨🇳Chongqing, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Shandong Provincial Hospital
🇨🇳Jinan, Shandong, China
Beijing You 'an Hospital, Capital Medical University
🇨🇳Beijing, China
The First Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Affiliated Cancer Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
Shijiazhuang Fifth Hospital
🇨🇳Shijiazhuang, Hebei, China
The Second Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
The Affiliated Zhongshan Hospital of Dalian University
🇨🇳Dalian, Liaoning, China
First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
The Second Hospital of Shandong University
🇨🇳Jinan, Shandong, China
The Affiliated Hospital of Qingdao University
🇨🇳Qingdao, Shandong, China
Chinese PLA General Hospital
🇨🇳Beijing, China
the Second Affiliated Hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, China
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, China