Clinical Trial of Cinobufacini Combined With Transarterial Chemoembolization (TACE) on Primary Liver Cancer
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- tumor size
研究概览
简要总结
The clinical trail of Cinobufacini combined with TACE on primary liver cancer.The trail is randomized controled.Patients are diagnosed primary liver cancer based on pathology or cell biology.They are randomized into 2 groups:both groups receive TACE.The treatment group receives Cinobufacini injection 20ml via hepatic artery during Transarterial Chemoembolization(TACE) operation , Cinobufacini injection 20ml+5% Glucose injection 500ml from the second day of TACE until 7th day, and Cinobufacini tablet 3 tablets Tid for 2 months..The control group only receives TACE.Mainly to study Cinobufacini leads to the influence of the immunologic function after TACE.Immunological examination and Blood biochemistry evaluation include the number ratio、activity and function of immune cell,the immune cell marker(CD3、CD4、CD8,etc),tumor marker(CEA、AFP),etc.Clinical evaluation includes image data(CT/MRI),drug toxicities,quality of life(QOL),etc.
详细描述
The clinical trail of Cinobufacini combined with TACE on primary liver cancer.The trail is randomized controled.Patients are diagnosed primary liver cancer based on pathology or cell biology.They are randomized into 2 groups:both groups receive TACE.The treatment group receives Cinobufacini injection 20ml via hepatic artery during Transarterial Chemoembolization(TACE) operation , Cinobufacini injection 20ml+5% Glucose injection 500ml from the second day of TACE until 7th day, and Cinobufacini tablet 3 tablets Tid for 2 months..The control group only receives TACE.Mainly to study Cinobufacini leads to the influence of the immunologic function after TACE.Immunological examination and Blood biochemistry evaluation include the number ratio、activity and function of immune cell,the immune cell marker(CD3、CD4、CD8,etc),tumor marker(CEA、AFP),etc.Clinical evaluation includes image data(CT/MRI),drug toxicities,quality of life(QOL),etc.
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
- 否
入选标准
- •Age:18-70 years.
- •male and female.
- •signed the informed consent form.
- •Diagnosis:Primary liver cancer diagnosed by imaging、cell and pathology report.
- •Eastern Cooperative Oncology Group (ECOG) :0-2;life expectancy more than 3 months.
- •Indication for TACE,no contraindication.
- •First time chemotherapy or at least 6 months after last chemotherapy and radiotherapy.
- •At least 8 weeks after last biotherapy.
- •Surgery：had not received transplantation surgery,at least 2 weeks after last major surgery.
排除标准
- •Chemotherapy is contraindicated.
- •Have the primary disease can cause the neuropathy.
- •A history of other malignant tumor in recent 5 years.
- •Less than 6 months after last chemotherapy or radiotherapy.
- •Less than 8 months after last.
- •Cinobufacini allergy.
- •Had received transplantation surgery ,less than 2 weeks after last major surgery.
- •Other researchers think is not suitable for this clinical trail.
研究组 & 干预措施
treatment group
The treatment group receives Cinobufacini injection 20ml via hepatic artery during Transarterial Chemoembolization(TACE) operation , Cinobufacini injection 20ml+5% Glucose injection 500ml from the second day of TACE until 7th day, and Cinobufacini tablet 3 tablets Tid for 2 months.
干预措施: Cinobufacini injection (Drug)
treatment group
The treatment group receives Cinobufacini injection 20ml via hepatic artery during Transarterial Chemoembolization(TACE) operation , Cinobufacini injection 20ml+5% Glucose injection 500ml from the second day of TACE until 7th day, and Cinobufacini tablet 3 tablets Tid for 2 months.
干预措施: Transarterial Chemoembolization(TACE) (Procedure)
treatment group
The treatment group receives Cinobufacini injection 20ml via hepatic artery during Transarterial Chemoembolization(TACE) operation , Cinobufacini injection 20ml+5% Glucose injection 500ml from the second day of TACE until 7th day, and Cinobufacini tablet 3 tablets Tid for 2 months.
干预措施: cinobufacini tablet (Drug)
control group
The control group only receives Transarterial Chemoembolization (TACE).
干预措施: Transarterial Chemoembolization(TACE) (Procedure)
结局指标
主要结局
tumor size
时间窗: the 8th week after TACE operation
次要结局
- the number of CD4+T cell,CD8+T cell in blood(the 8th week after TACE operation)
- Interleukin(IL)-2,Interleukin(IL)-4,Interleukin(IL)-6,tumor necrosis factor(TNF)-α，interferon(INF)-γ in blood(the 8th week after TACE operation)