NCT01125020Unknown不适用
Impact of Postoperative Adjuvant Chemotherapy in Patients With Hepatocellular Carcinoma After Liver Transplantation
Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2008年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- tumor recurrence and metastasis
研究概览
简要总结
The study is designed to investigate the effect of postoperative adjuvant chemotherapy in prevention of tumor recurrence and metastasis 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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All liver transplantation patients with hepatocellular carcinoma between Dec 2008 and May 2010 are potentially eligible for enrollment.
排除标准
- •Age less than 18 years
- •Treatment with other postoperative adjuvant chemotherapy
- •Survival is less than 3 months after liver transplantation
- •Inability to provide written informed consent prior to study entry
研究组 & 干预措施
gemcitabine and oxaliplatin
Active Comparator
干预措施: gemcitabine and oxaliplatin (Drug)
doxorubicin, 5-Fu and cisplatin
Active Comparator
干预措施: doxorubicin, 5-Fu and cisplatin (Drug)
结局指标
主要结局
tumor recurrence and metastasis
时间窗: within the first year after liver transplantation
Examination of tumor recurrence include serum levels of alpha-fetoprotein(AFP), chest radiography, abdominal ultrasonography, chest or abdominal computed tomography (CT), magnetic resonance imaging (MRI) and bone scintigraphy
次要结局
- Postoperative survival(within the first year after liver transplantation)
研究者
研究点 (1)
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