NCT01102335Unknown4 期
The Observation Of Safety And Survival Of Hepatocellular Carcinoma After Transcatheter Arterial Chemoembolization Combined With Anti-hepatitis B Virus Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
The purpose of this study is to elucidate the influence of anti-hepatitis B virus therapy on safety and survival of HCC patient after transcatheter arterial chemoembolization.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hepatocellular carcinoma
- •treated with transcatheter arterial chemoembolization (TACE)
- •HBVDNA > 10^3copies/mL, including alanine aminotransferase (ALT) normal patient
- •expected survive time > 1 year
- •HBV marker positive (anyone of HbsAg, HbsAb, HbeAg, HbeAb and HbcAb)
排除标准
- •antiviral therapy history
- •alanine aminotransferase (ALT) >400 U/L
- •serum total bilirubin > 50 μmol/L
- •HBVDNA > 10^9copies/mL
- •extrahepatic metastasis or main portal vein embolus
- •apparent cardiac or pulmonary dysfunction
- •liver function: Child B or Child C
- •HCV infection
研究组 & 干预措施
Telbivudine
Experimental
干预措施: Transcatheter arterial chemoembolization (TACE) (Procedure)
Telbivudine
Experimental
干预措施: Telbivudine (Drug)
TACE only
Active Comparator
干预措施: Transcatheter arterial chemoembolization (TACE) (Procedure)
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: 6 months
次要结局
- Overall survival(2 years)
研究者
研究点 (1)
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