NCT01270178Unknown不适用
Prospective Trial of Entecavir for Chronic Hepatitis B in Hepatocellular Carcinoma Patients Underwent Radiofrequency Ablation Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- The survival rate and recurrence rate between patients receiving ETV therapy and those in historical control
研究概览
简要总结
Persistent replication of HBV (47-55%) is frequently found in patients with HCC, which in turn leads to deterioration of liver reserve. Moreover, a large proportion of HCC patients who underwent curative therapy died from progressive liver decompensation rather than recurrence of cancer. It had been proved that anti-viral therapy for hepatitis C virus (HCV)-related HCC patients could reduce the rate of tumor recurrence after surgical resection.
This is a prospective study to evaluate the efficacy of ETV therapy in chronic hepatitis B patients after receiving RFA therapy for HCC.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCC diagnosed by pathology verification or in accordance with the guidelines of American Association for the Study of Liver Diseases published in 2010 (typical vascular pattern in computed tomography scan or magnetic resonance imaging study) ,
- •Solitary tumor less than 5 cm in diameter or 2-3 tumors with the largest one no more than 3 cm in diameter,
- •No extrahepatic metastasis,
- •No radiological evidence of invasion into major portal vein or hepatic vein branches,
- •Good liver reserve with Child-Pugh Class A or B,
- •A platelet count of more than 50,000/mm3,
- •Serum creatinine level ≤ 2 mg/dL,
- •No previous treatment for HCC,
- •Positive for serum hepatitis B surface antigen (HBsAg) for more than 6 months
- •Positive serum HBV DNA using a Cobas Amplicor HBV monitor (Roche Diagnostic System, Basel, Switzerland).
排除标准
- •Dual or multiple infections with hepatitis C virus, hepatitis D virus, or the human immunodeficiency virus,
- •Other forms of liver disease such as alcoholic hepatitis, autoimmune hepatitis, Wilson's disease, hemochromatosis,
- •Use of interferon alpha, thymosin or antiviral agents within 6 months preceding entry into the study,
- •Women who are pregnant or nursing.
研究组 & 干预措施
Entecavir
干预措施: Entecavir (Drug)
结局指标
主要结局
The survival rate and recurrence rate between patients receiving ETV therapy and those in historical control
时间窗: 3 years
次要结局
- HBV reactivation, incidence of ALT normalization, reduction of serum HBV DNA level, HBsAg loss and HBsAg seroconversion to anti-HBsAb, emergence of resistance.(3 years)
研究者
研究点 (1)
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