NCT02026362暂停1 期
Randomized, Open-label, Multi-center Clinical Trial to Compare the Efficacy and Safety of MASCT Group' and 'Non-treatment Group' in Patient Undergone Curative Resection( RFA or Operation) for Hepatocellular Carcinoma .MASCT That Expresses Multiple Antigens Specific Cellular Therapy,Autologous Immune Cytotoxic of T-lymphocytes(CTL) Induced by Dendritic Cell(DC) Loaded With Multiple Antigens
HRYZ Biotech Co.1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of Participants with tumor recurrence or metastasis
研究概览
简要总结
To prove that the efficacy and safety of 'MASCT group' is superior to 'non-treatment group' in patient undergone curative resection (RFA or operation) for hepatocellular carcinoma in China.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is diagnosed as hepatocellular carcinoma(HCC);
- •The patient underwent radical operation of HCC within 8 weeks before enrollment;
- •The number of tumors≤2；
- •No cancer embolus in the main portal vein and first branch, hepatic duct and first branch, hepatic vein, inferior vena cava;
- •No portal lymph node metastasis；
- •No extra-hepatic metastasis;
- •Complete tumor resection without residual tumor at the surgical margins should be confirmed by enhanced CT or MRI imaging within 4 week (including 4 weeks) after radical operation;
- •If an increased serum AFP level was detected of the patient before the radical operation, the AFP level should be returned to normal in 8 weeks;
- •Child-Pugh Score ≤9;
- •ECOG Performance status (ECOG-PS) ≤2 ;
- •The expected survival time > 2 years;
- •Tests of blood,liver and kidney should meet the following criteria：
- •WBC>3×109/L
- •Neutrophil counts >1.5×109/L
- •Hemoglobin ≥85 g/L
- •Platelet counts≥50×109/L
- •PT is normal or The extend time <3s
- •BUN≤1.5 times the upper-limit ,
- •Serum creatinine≤ 1.5 times of the upper-limit
- •Sign the informed consent.
排除标准
- •Women who is pregnant or during breast feeding or plan to pregnant in 2 years;
- •Extra-hepatic metastasis or liver residual tumor;
- •Cancer embolus in the main portal vein and first branch, Hepatic duct and first branch, hepatic vein, inferior vena cava;
- •6 months before enrollment: the period of systemic and continuous use of immunomodulatory agents (such as interferon, thymosin, traditional Chinese medicine) was longer than 3 months;
- •6 months before enrollment: the period of systemic and continuous use of the immunosuppressive drugs (such as corticosteroids drug) was longer than 1 months;
- •Received any cell therapy (including NK, CIK, DC, CTL, stem cells therapy) in 6 months before enrollment;
- •Positive for HIV antibody or HCV antibody;
- •Have a history of immunodeficiency disease or autoimmune diseases (such as rheumatoid arthritis, Buerger's disease, multiple sclerosis and diabetes type 1);
- •Patient who suffered from other malignant tumor in 5 years before enrollment (except skin cancer, localized prostate cancer or cervix carcinoma);
- •. Patients with organ failure;
- •Patients with serious mental disease;
- •Drug addiction in 1year before enrollment (including alcoholics);
- •Participated in other clinical trials in 3 months before screening;
- •Other reasons the researchers think not suitable.
研究组 & 干预措施
The foundation treatment after radical operation or RFA
Other
The foundation treatment including against hepatitis b virus treatment using nucleoside analogue drug and protect liver treatment
干预措施: The foundation treatment including against hepatitis b virus treatment using nucleoside analogue drug and protect liver treatment (Other)
MASCT:Multiple Antigens Specific Cellular Therapy
Experimental
autologous immune cytotoxic of T-lymphocytes (CTL) induced by dendritic cells, (DC) loaded with multiple antigens DC loaded with survivin p53 her2 ect total 17 antigens
干预措施: MASCT:Multiple Antigens Specific Cellular Therapy (Biological)
MASCT:Multiple Antigens Specific Cellular Therapy
Experimental
autologous immune cytotoxic of T-lymphocytes (CTL) induced by dendritic cells, (DC) loaded with multiple antigens DC loaded with survivin p53 her2 ect total 17 antigens
干预措施: The foundation treatment including against hepatitis b virus treatment using nucleoside analogue drug and protect liver treatment (Other)
结局指标
主要结局
Number of Participants with tumor recurrence or metastasis
时间窗: 5years
Time of tumor recurrence or metastasis
时间窗: 5 years
次要结局
- Hepatitis B virus markers figures(an expected average of 18 weeks)
- Serum hepatitis B virus (HBV)DNA figures(an expected average of 16 weeks)
- overall survival(5 years)
研究者
研究点 (1)
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