A Clinical Study of Adoptive Cellular Immunotherapy Using Pluripotent Killer T Cells Expressing Antibodies for Human Epidermal Growth Factor Receptor-2 (HER2) in Treating Patients With HER2-Positive Advanced Gastric Cancer With Liver Metastasis
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Objectives:
The purpose of this study is to evaluate the safety and efficacy of PIK-HER2 cells in the treatment of advanced Her2 high expressed gastric cancer with liver metastasis patients.
Methods:
This study designs a novel therapy using PIK-HER2 cells. 40 Her2 positive patients with liver metastasis from gastric cancer will be enrolled. They are randomly divided into dendritic cell-precision multiple antigen T cells (DC-PMAT) group and PIK-HER2 cells group. Both DC-PMAT treatment and PIK-HER2 cells treatment will be performed every 3 weeks with a total of three periods. The mail clinical indicators are Progression-Free-Survival and Overall Survival.
详细描述
A total of 40 patients may be enrolled over a period of 1-2 years.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18~65 years old, male or female
- •Life expectancy > 6 months
- •Eastern Cooperative Oncology Group (ECOG) score: 0-2
- •The stomach or gastroesophageal junction carcinoma with hepatic metastasis
- •Adenocarcinoma
- •The expression of HER2 in immunohistochemical tumor tissue should be greater than or equal to 2 levels
- •Creatinine is less than 2.5mg/dL; alanine aminotransferase (ALT) / aspartate aminotransferase(AST)T less than 3 times of the normal; bilirubin is less than 3mg/dL
- •Blood routine conforms to the requirements of the blood sampling
- •Signed informed consent
- •Patients with fertility are willing to use contraceptive method.
排除标准
- •Expected Overall survival < 6 months
- •Other serious diseases:the heart,lung,kidney, digestive, nervous, mental disorders, immune regulatory diseases,metabolic diseases, infectious diseases, Etc.
- •Serum creatinine > 2.5mg/dL;Serum Glutamic Oxaloacetic Transaminase (SGOT) > 5 times of the normal;total bilirubin > 100μmol/L
- •Without signed informed consent.
结局指标
主要结局
Overall survival
时间窗: 2 years
次要结局
- Progress-free survival(2 years)
- Quality of life(2 years)