NCT02150317Unknown不适用
A Prospective Randomized Trial Comparing Transcatheter Arterial Chemoembolization (TACE) Followed by Sorafenib Versus TACE Alone for Advanced Hepatocellular Carcinoma
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
- the overall survival rate 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) followed by Sorafenib with TACE alone in patients with advanced hepatocellular carcinoma.
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.
- •at least 2 radiologic imaging showing characteristic features of hepatocellular carcinoma or cytologic/histologic evidence.
- •tumor in liver and radiologically definable vascular invasion or extrahepatic metastasis.
- •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.
- •No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal.
- •Hb ≥90g/L,white blood cell count ≥3.000 cells/mm³,platelets ≥80.000 cells/mm³
- •Patients who can understand this trial and have signed information consent
排除标准
- •Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer.
- •Patients with other diseases which may affect the treatment mentioned.
- •Patients with a medical history of other malignant tumors.
- •Subjects participating in other clinical trials.
- •liver function:Child C.
- •no pathological evidence of hepatocellular carcinoma.
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
vice president of the Eastern Hepatobiliary Surgery Hospital
Eastern Hepatobiliary Surgery Hospital
研究点 (1)
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