Effect of Adjuvant Therapy by Sorafenib, Oxaliplatin and S-1o Prevent the Tumor Recurrence for Hepatocellular Carcinoma After Liver Transplantation: A Randomized Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Time to Recurrence (TTR)
研究概览
简要总结
The study is designed to investigate the effect of adjuvant therapy by Sorafenib, Oxaliplatin and S-1 to prevent the tumor recurrence for hepatocellular carcinoma after liver transplantation
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hepatocellular carcinoma after liver transplantation
- •Major organ (heart, lung and brain) function was normal
排除标准
- •Any active infectious process
- •The presence of clinically confirmed extrahepatic metastasis
- •Postoperative dysfunction of any organ
研究组 & 干预措施
Sorafenib
Leading 4 cycles: S-1 + Oxaliplatin Q3W + Sorafenib daily Sequential : Sorafenib maintenance
干预措施: Sorafenib (Drug)
Sorafenib
Leading 4 cycles: S-1 + Oxaliplatin Q3W + Sorafenib daily Sequential : Sorafenib maintenance
干预措施: S-1 (Drug)
Sorafenib
Leading 4 cycles: S-1 + Oxaliplatin Q3W + Sorafenib daily Sequential : Sorafenib maintenance
干预措施: Oxaliplatin (Drug)
S-1 and Sorafenib
Leading 4 cycles: S-1 + Oxaliplatin Q3W + Sorafenib daily Sequential : 4 cycles of S-1 + Sorafenib maintenance
干预措施: Sorafenib (Drug)
S-1 and Sorafenib
Leading 4 cycles: S-1 + Oxaliplatin Q3W + Sorafenib daily Sequential : 4 cycles of S-1 + Sorafenib maintenance
干预措施: S-1 (Drug)
S-1 and Sorafenib
Leading 4 cycles: S-1 + Oxaliplatin Q3W + Sorafenib daily Sequential : 4 cycles of S-1 + Sorafenib maintenance
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Time to Recurrence (TTR)
时间窗: within five years after liver transplantation
Time to Recurrence
次要结局
- Overall survival (OS)(within the five years after liver transplantation)
研究者
Weijia Fang, MD
First affiliated hospital, Zhejiang University
Zhejiang University