De Novo Sirolimus-based Immunosuppression After Liver Transplantation for Hepatocellular Carcinoma: Long-Term Outcomes and Side Effects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Percentage of Participants Surviving at One and Four Years After Liver Transplant
研究概览
简要总结
This study investigates whether sirolimus could decrease the rate of hepatoma recurrence after liver transplantation in high risk hepatoma patients.
详细描述
A total of 70 patients with HCC (mean age: 54.6 years, female/male: 12/58) received a liver transplant and were included in the study. Immunosuppression included de novo sirolimus, low-dose calcineurin inhibitor for 6 to 12 months, with short-course (3 months) or no steroids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with hepatocellular (HCC) carcinoma receiving liver transplant
- •Exclusion criteria:
- •Patients less than 18 years of age
排除标准
- 未提供
研究组 & 干预措施
Sirolimus based immunosuppression
Sirolimus given intravenously or orally to achieve serum level of 12-20ug/l
干预措施: Sirolimus (Drug)
结局指标
主要结局
Percentage of Participants Surviving at One and Four Years After Liver Transplant
时间窗: 1 & 4 years
Percent of Patients Surviving at One \& Four years after Liver Transplant was calculated
Percentage of Participants Surviving With no Evidence of Recurrent Tumor at One and Four Years After Liver Transplant
时间窗: 1 and 4 years
Percentage of Participants Surviving with no Evidence of Recurrent Hepatocellular Carcinoma at One and Four Years After Liver Transplant
次要结局
- Sirolimus Toxicity/Intolerance(1 year)
研究者
Norman Kneteman
Co-zone Clinical Section Chief, Transplants/NARP
University of Alberta