The Risk of Exacerbation of Chronic Hepatitis B After Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The Rate of Exacerbation of chronic hepatitis B after RFA
研究概览
简要总结
This study aim to find out the risk of exacerbation of chronic hepatitis B after percutaneous radiofrequency ablation (RFA) or hepatectomy for HCC, and it's effect to treatment outcome.
详细描述
It has been reported that HBV replication can be reacted after chemotherapy or immunotherapy, which will lead to exacerbation of chronic hepatitis B (ECHB). It is still unknown that if percutaneous radiofrequency ablation or liver resection for hepatocellular carcinoma (HCC) will react the replication of HBV or not. This study aim to find out the risk of exacerbation of chronic hepatitis B after percutaneous radiofrequency ablation (RFA) or hepatectomy for HCC, and it's effect to treatment outcome.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 75 years
- •HBV carrier with HCC
- •After percutaneous radiofrequency ablation;
- •No history of encephalopathy, ascites refractory to diuretics or variceal bleeding
- •No HCV or HIV co-infection
- •No previous treatment of HCC
- •No previous treatment of HBV except Lamivudine
排除标准
- •Patient compliance is poor
- •Active clinically serious infections ( > grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)
- •Known history of human immunodeficiency virus (HIV) infection
- •Known Central Nervous System tumors including metastatic brain disease
- •Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
- •Distantly extrahepatic metastasis
- •History of organ allograft
- •Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- •Excluded therapies and medications, previous and concomitant
- •Prior use of any systemic anti-cancer treatment for HCC, eg. chemotherapy, immunotherapy or hormonal therapy (except that hormonal therapy for supportive care is permitted). Antiviral treatment is allowed, however interferon therapy must be stopped at least 4 weeks prior randomization
- •Prior use of systemic investigational agents for HCC
- •Autologous bone marrow transplant or stem cell rescue within four months of start of study drug
结局指标
主要结局
The Rate of Exacerbation of chronic hepatitis B after RFA
时间窗: one week, one month, one year
次要结局
- survival(1, 3, 5-year)
- mortality(one month)