NCT03356236RecruitingNot Applicable
A Multicenter, Prospective Cohort Study Investigating Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma Following Local Ablation
Yue Han17 sites in 1 country828 target enrollmentStarted: April 17, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 828
- Locations
- 17
- Primary Endpoint
- Progression-free survival (PFS)
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Progression-free survival (PFS)
Time Frame: 96 weeks
PFS was defined as the duration of time from start of treatment to time of disease progression.
Secondary Outcomes
- Recurrence-Free Survival (RFS)(96 weeks)
- Overall Survival (OS)(Time from baseline to death (up to 96 weeks))
- Change From Baseline in Quality of Life (QOL)(24, 48, 72, 96 weeks)
- Time to recurrence (TTR)(Time from baseline to relapse (up to 96 weeks))
- severity of Adverse events (AE)(96 weeks)
- Incidence rate of Adverse events (AE)(96 weeks)
Investigators
Yue Han
Professor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study Sites (17)
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