NCT02724267已完成不适用
A Randomized Controlled Prospective Study of Targeted Internal Radiation Therapy in Patients With Advanced Hepatocellular Carcinoma.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
The aim of this study is to evaluate the 131I-chTNT-1/B treatment effect and safety of individual therapy using randomized controlled study, in order to acquire the evidence of evidence-based medicine and create a new program of targeted internal radiation therapy in advanced HCC 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
- 是
入选标准
- •Via clinical diagnosis and confirm it is advanced hepatocellular carcinoma
- •mRECIST estimation: necrosis region in HCC
- •Negative iodine allergy test
- •Liver function ：Child-Pugh A/B
排除标准
- •reject to attend；
- •impossible to come to our hospital for physical examination regularly.
- •Blood clotting function hindrance; 4, Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer.
研究组 & 干预措施
transcatheter arterial chemoembolization
Active Comparator
Patients will be treated with TACE only.
干预措施: 131I-chTNT-1/B (Biological)
internal radiation group
Experimental
Patients will be treated with TACE combined with internal radiation.
干预措施: 131I-chTNT-1/B (Biological)
结局指标
主要结局
Overall Survival
时间窗: 3 years
次要结局
- Time to Progression(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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