A Prospective, Randomized, Multicenter, Open-label, Exploratory Study of Utilizing of Peginterferon Alfa-2a on the Relapse Rate of the Subjects With Hepatocellular Carcinoma Who Have Been Treated by Resection
试验速览
- 阶段
- 4 期
- 入组人数
- 432
- 试验地点
- 1
- 主要终点
- Recurrence-free Survival Rate (RFS）
研究概览
简要总结
The current study is a prospective, randomized, open, multi-center investigation. The aim of current study is to investigate whether the Recurrence-free Survival Rate (RFS）of the hepatitis B related -hepatocellular carcinoma subjects who have been treated by resection can be improved by peginterferon alfa-2a
详细描述
The subjects who have been treated by resection due to hepatocellular carcinoma (HCC) will be randomized into 2 groups: the subjects in group A will be treated by Nucleotide analogues (NAs)( ETV, 0.5mg，qd；tenofovir disoproxil fumarate(TDF)，300mg，qd；ADV，10mg，qd）for 96 weeks; the subjects in group B will be treated by peginterferon alfa-2a （135μg/week）combination with NAs (ETV\TDF\ADV)for 96 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients with age ≥18 and ≤70 years;
- •Expected survival time >3 months;
- •There should be evidences that chronic hepatitis B or hepatitis have been positive, hepatitis B virus (HBV) DNA detectable or undetectable, Alanine aminotransferase(ALT)<upper limit of normal (ULN) or ≥ULN；
- •The patients have been treated by resection due to HCC;
- •The characteristic of tumor should be:Barcelona Clinic Liver Cancer(BCLC): 0,A,B
- •Child-Pugh scores:A
- •Agree to participate in the study and sign the patient informed consent form.
排除标准
- •Patients that have been treated by live transplantation、chemoembolization、radiotherapy、chemotherapy、molecular targeted therapy and biotherapy before the resection;
- •Patients that are treated by hepatotoxicity drugs 、immunosuppressant or adjuvant chemotherapy after the resection;
- •Patients who be treated by transcatheter arterial chemoembolization(TACE) after resection;
- •BCLC(Barcelona Clinic Liver Cancer):C、D before the resection;
- •History or other evidence of malignant tumor: except by basal cell carcinoma or squamous cell carcinoma which are cured 、carcinoma in situs of cervix
- •Allergic history to interferon;
- •Co-infection with active hepatitis A, hepatitis C, hepatitis D and/or human immunodeficiency virus (HIV);
- •History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures, thalassemia);
- •absolute neutrophil count(ANC)<1.5x 10^9/L or platelet count(PLT)<70x 10^9/L
- •Creatinine over upper limit of normal;
- •History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as major depression or psychosis that treated with antidepressant medication or a major tranquilizer at therapeutic doses respectively at any time prior to 3 months or any history of the following: a suicidal attempt hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease;
- •History of severe cardiac disease (e.g., New York Heart Association Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases);
- •History of thyroid disease poorly controlled on prescribed medications;
- •Evidence of severe retinopathy or clinically relevant ophthalmologic disorder;
- •History of other severe disease or evidence of other severe disease or any other illness or conditions that the investigator believe that patients are not suitable to join in the study;
- •Evidence of postoperative complications: infectious、bleeding, etc,. at baseline; or evidence of recurrence or metastasis at baseline;
- •Child-Pugh scores :B、C
- •Patients included in another trial or having been given investigational drugs within 12 weeks prior to screening;
- •Other disease should exclusive considered by the investigator.
研究组 & 干预措施
Group B
The subjects will be treated by peginterferon alfa-2a （135μg/week）combination with NAs(ETV\TDF\ADV) for 96 weeks.
干预措施: Peginterferon Alfa-2a (Drug)
Group A
The subjects will be treated by NAs (ETV, 0.5mg，qd；TDF，300mg，qd；ADV，10mg，qd）for 96 weeks
干预措施: ETV；TDF；ADV (Drug)
Group B
The subjects will be treated by peginterferon alfa-2a （135μg/week）combination with NAs(ETV\TDF\ADV) for 96 weeks.
干预措施: ETV；TDF；ADV (Drug)
结局指标
主要结局
Recurrence-free Survival Rate (RFS）
时间窗: 2 years
Number of subjects without Recurrence in the total subjects
次要结局
- Recurrence-free Survival Rate (RFS）(1 year)
- Overall Survival Rate (OS）(1 year)
研究者
Jiming Zhang
Deputy director of department
Huashan Hospital