NCT01936233Unknown3 期
Liver Cancer Institiute ,Fudan University
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- recurrence free survival
研究概览
简要总结
Evaluation the Treatment Outcome of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery.
详细描述
The investigators conduct this clinical trial to evaluate the treatment outcome of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery.The primary outcome is overall survival and objective response rate.
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 confirmed with pathology or identified with radiological images with typical features
- •Age ≥ 18 years and ≤ 75 years
- •At least one tumor nodule with one uni-dimension of ≥ 2 cm
- •Child-Pugh Class A or B
- •HBV-DNA>10^4
- •Total bilirubin ≤ 1.5 x upper limit of normal
- •ALT and AST ≤ 2.0 x the upper limit of normal
- •PT-INR<2.3,PTT < 1.5 x upper limit of normal
- •Serum creatinine ≤ 1.5x upper limit of normal
- •Peripheral white blood cell count of or more than 3×10(9)/L
- •Peripheral platelet of or more than 50×10(9)/L
- •Expected survival time not less than 3 months
- •ECOG score 0-2
排除标准
- •Tumor thrombi in main branch of portal vein
- •Tumor involvement more than 70% of whole liver
- •With extrahepatic metastasis
- •Prior systemic chemotherapy or chemoembolization
- •Congestive heart failure > NYHA class 2
- •History of HIV infection
- •Active clinically serious infections (> 2 NCI-CTC Version 3.0)
- •Recurrence of HCC after liver transplantation
- •Pregnant or breast-feeding
- •Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in this study
- •Known or suspected allergy to any agent given in association with this trial
- •Patients unable to swallow oral medication
- •Inclined to thrombosis
- •Inclined to hemorrhage or active hemorrhage with 1 month
研究组 & 干预措施
Aspirin AND Lamivudine
Experimental
干预措施: Aspirin (Drug)
Aspirin AND Lamivudine
Experimental
干预措施: Lamivudine (Drug)
Lamivudine
Active Comparator
干预措施: Lamivudine (Drug)
结局指标
主要结局
recurrence free survival
时间窗: 36 months
次要结局
- overall survival(36 months)
- adverse events(36 months)
研究者
Zheng-Gang Ren
chief of departement
Fudan University
研究点 (1)
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