NCT02588755Unknown不适用
Anti-tumor Recurrence With Transarterial Chemoembolization (TACE) Plus Tegafur Versus TACE on Patients With Intrahepatic Cholangiocarcinoma After Curative Resection：A Randomized Controlled Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Overall survival rates of each group
研究概览
简要总结
The aim of this study is to compare the outcomes of Transarterial Chemoembolization (TACE) plus Tegafur with TACE alone in patients with intrahepatic cholangiocarcinoma after curative resection
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
- Triple (Participant, Care Provider, Investigator)
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
- •Male or female patients > 18 years and <=70 years of age.
- •Pathological evidence of ICC
- •Tumors can be completely resected.
- •Criteria of liver function: Child A-B 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.
- •Patients who can understand this trial and have signed information consent.
排除标准
- •Tumors can not be resected .
- •Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction, which may affect the treatment of Intrahepatic cholangiocarcinoma.
- •Patients with a medical history of other malignant tumors.
- •Subjects participating in other clinical trials.
- •Liver function:Child C.
结局指标
主要结局
Overall survival rates of each group
时间窗: 3 years
次要结局
- Occurrence rate of recurrence of each group(3 years)
研究者
ShenFeng
vice president of the Eastern Hepatobiliary Surgery Hospital
Eastern Hepatobiliary Surgery Hospital
研究点 (1)
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