Adjuvant Entecavir or Tenofovir for Hepatitis B Virus Related Hepatocellular Carcinoma After Curative Hepatic Resection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
This study aims to compare the effect of antiviral therapy with entecavir or tenofovir for hepatitis B virus-related hepatocellular carcinoma after radical hepatectomy. Included patients will randomly divide into two groups.
详细描述
Hepatocellular carcinoma (HCC) is associated with a poor prognosis, and its incidence has increased dramatically in many countries. Hepatectomy is a radical therapy for early-stage HCC. However, even after radical resection, the prognosis for HCC patients remains discouraging because of the high recurrence rate and frequent incidence of intrahepatic metastasis. Therefore, preventing HCC recurrence is very important.
Hepatitis B virus (HBV) infection is the major risk factor for HCC development in China. Some retrospective studies have shown that tenofovir or entecavir treatment for HBV-related HCC patients can effectively reduce the HCC recurrence rate and increase the survival rate after hepatectomy. However, which drug has more efficacy has not been addressed.
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
- Double (Participant, Care Provider)
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
- 是
入选标准
- •Underwent hepatic resection.
- •Diagnosis of HCC was confirmed by postoperative histopathology.
- •Positive of HBsAg, HBeAg, or HBV DNA.
- •Child-Pugh A or B liver function.
排除标准
- •Anti-HCV(+)
- •Diagnosis of HCC was not confirmed by postoperative histopathology of surgical samples after surgery.
研究组 & 干预措施
Entecavir
Patients will be received entecavir (10 mg/d) after 3 days of liver resection.
干预措施: Entecavir (Drug)
Tenofovir
Patients will be received tenofovir (1#/d) after 3 days of liver resection.
干预措施: Tenofovir (Drug)
结局指标
主要结局
overall survival
时间窗: 1-year
次要结局
- Recurrence rate(1-year)
研究者
Jian-Hong Zhong
Director
Guangxi Medical University