NCT01236690Unknown2 期
The Clinical Research of the Intermediate and Advanced Hepatoma Treated by Cinobufacin by Perfusion of Hepatic Artery Combining the Arterial Embolotherapy
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 284
- 试验地点
- 1
- 主要终点
- The evaluation of the patient's respondence for the therapy is carried out every phase, according to RECIST:CR,PR,SD and PD.
研究概览
简要总结
Cinobufacini has the effects of anticancer, improving the liver function, elevation of immunity and little side effects, and is important and significant for the patients with hepatitis, liver cirrhosis and hepatomas.
Compared with transarterial chemoembolization (TACE) , the clinical effect of cinobufacini is non-inferior/ equivalent.Compared with TACE, cinobufacini is superior in security .
详细描述
Inclusion criterion :
- The sex does not limit, age:18-70 years old .
- The patients have inoperable advanced hepatoma without serious disorder in liver and renal, tumor occupation< 70 %
- The patients have failure in surgical intervention or resection operation recidivist
- Hepatic function Child-pugh A、B
- All the cases have the definite final diagnosis of imageology results such as MRI、CT 、B ultrasonic or cytology results
- The patient's prediction of live time>6 months, who can tolerant of TACE and has quality of life ECOG score<3
- The patients participate the clinical trial voluntarily and have already signed informed consent
Exclusion criterion :
- Main portal vein was obstructed completely.
- The occupation of tumor are 70 % or more than 70 % in the whole liver
- The patient has TACE or other antineoplaston
- After carcinosectomy the patient has the prophylactic
- The patient is with renal inadequacy: Cr≥133 umol/L
- Severe cardiovascular disease
- The patient is with other diseases to influence the proposal
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
- •The sex does not limit, age:18-70 years old ;
- •The patients have inoperable advanced hepatoma without serious disorder in liver and renal, tumor occupation< 70 %;
- •The patients have failure in surgical intervention or resection operation recidivist;
- •Hepatic function Child-pugh A、B;
- •All the cases have the definite final diagnosis of imageology results such as MRI、CT 、B ultrasonic or cytology results ;
- •The patient's prediction of live time>6 months, who can tolerant of TACE and has quality of life ECOG score<3;
- •The patients participate the clinical trial voluntarily and have already signed informed consent.
排除标准
- •Main portal vein was obstructed completely;
- •The occupation of tumour are 70 % or more than 70 % in the whole liver;
- •The patient has recepted TACE or other antineoplaston;
- •After carcinosectomy the patient has the prophylactic;
- •The patient is with renal inadequacy: Cr≥133 umol/L
- •Severe cardiovascular disease;
- •The patient is with other diseases to influence the proposal;
- •All over the body generally have metabasis or be with other malignant neoplastic disease;
- •In the process of participation of other medicinal trial;
- •Gravidity, lactation ,hypersensitiveness constitution or have already known adverse reaction or taboo.
结局指标
主要结局
The evaluation of the patient's respondence for the therapy is carried out every phase, according to RECIST:CR,PR,SD and PD.
时间窗: Nov. 2010 to Nov. 2013
The evaluation of the patient's respondence for the therapy is carried out every phase, according to RECIST:CR,PR,SD and PD.
次要结局
未报告次要终点
研究者
研究点 (1)
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