NCT02580929Unknown不适用
Effectiveness of Radiotherapy Before Surgery in Patients With High-risk Relapse Hepatocellular Carcinoma
Peking Union Medical College1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- mortality
研究概览
简要总结
This study aims to evaluate the effectiveness of radiotherapy before surgery in high-risk relapse hepatocellular cancer patients.
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
- •Clinical diagnosis of HCC
- •In high risk of recurrence of HCC but still can endure palliative resection
- •KPS scores are >90
- •With Child-Pugh Class A liver funcion, serum bilirubin< 1.5*normal maxism; ALT and AST< 1.5*normal maxism; normal creatinine and urea nitrogen; WBC>4×109/L, Hb>110g/L, PLT>90X109/L.
- •Have signed informed consent
排除标准
- •HCC cannot be operated
- •With Child-Pugh Class B/C
- •Have other organ cancer, excluding curative non-melanotic skin cancer and carcinoma in situ of cervix
- •Have other severe disease
- •With active hepatitis
- •Have accepted local radiation therapy in other hospitals
- •KPS scores≤70
- •Tumor edges cannot be defined
- •Have severe cirrhosis complication
- •Intensity modulated radiation therapy cannot reach required dose
- •Cannot cooperate
- •Lactant or pregnant
- •Cannnot be informed
结局指标
主要结局
mortality
时间窗: 5 years
次要结局
未报告次要终点
研究者
WU FAN
Doctor
Peking Union Medical College
研究点 (1)
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