Entecavir for Chronic Hepatitis B in Hepatocellular Carcinoma Patients Underwent Radiofrequency Ablation Therapy
Prospective Trial of Entecavir for Chronic Hepatitis B in Hepatocellular Carcinoma Patients Underwent Radiofrequency Ablation Therapy
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.
研究概览
研究类型
注册 (预期的)
联系人和位置
学习地点
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Taipei、台湾
- Department of Medicine, Taipei Veterans General Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Entecavir
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film coated tablets / 0.5mg / once daily / 3 years
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
The survival rate and recurrence rate between patients receiving ETV therapy and those in historical control
大体时间:3 years
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3 years
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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HBV reactivation, incidence of ALT normalization, reduction of serum HBV DNA level, HBsAg loss and HBsAg seroconversion to anti-HBsAb, emergence of resistance.
大体时间:3 years
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3 years
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合作者和调查者
研究记录日期
研究主要日期
学习开始
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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