NCT01914289Unknown不适用
Comparison of Resection and Radiotherapy in the Prognosis of Intrahepatic Cholangiocarcinoma Patients
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- the overall survival rate of each group
研究概览
简要总结
The purpose of this study is to confirm that prognosis of Intrahepatic Cholangiocarcinoma (ICC) with resection and radiotherapy ,to find which is safe and effective treatment.
详细描述
Intrahepatic Cholangiocarcinoma (ICC), the second most common primary liver cancer and constitutes 10% of primary liver malignancies.
Current therapies for the treatment of ICC are ineffective and the role of liver transplantation is not well defined.
This study reviews our experience with this tumor and looks for preoperative and pathologic indices that may help determine long term prognosis
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
- 17 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients > 17 years and <=60 years of age. confirmed case (patients with ICC) Tumors can be radical removed and resection volume was ≤50%. Criteria of liver function: Child A level, serum bilirubin ≤ 1.5 times the upper limit of normal value,alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.
- •No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal. Hbg ≥ 90g/L, WBC ≥ 3.000 cells/mm³,platelets ≥ 80.000 cells/mm³.
- •Karnofsky Performance Score performance over
- •Patients who can understand this trial and have signed information consent.
排除标准
- •Patients who have undergone previous treatment by Resection or Radiotherapy. Patients with apparent cardiac, pulmonary, cerebronic and renal dysfunction, which may affect the treatment of liver cancer.
- •Patients with other diseases which may affect the treatment mentioned here. Patients with medical history of other malignant tumors. Subjects participating in other clinical trials. Extrahepatic metastasis, portal vein or other major vascular involvement. liver function: Child B C.
- •Patients would not sign the consent to the trial.
结局指标
主要结局
the overall survival rate of each group
时间窗: 3 years
次要结局
未报告次要终点
研究者
ShenFeng
director of department of special treatment
Eastern Hepatobiliary Surgery Hospital
研究点 (1)
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