Clinical Study Using Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Gastric Cancer
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Progress-free survival
研究概览
简要总结
To evaluate the safety and effectiveness of cell therapy using Precision Cells to treat Advanced Gastric Cancer.
Eligibility:
Individuals greater than or equal to 18 years of age and less than or equal to 65 years of age who have been diagnosed with Advanced Gastric Cancer.
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;
- •ECOG score: 0-3;
- •Advanced Malignancies (gastric cancer) were diagnosed by pathological or clinical physicians;
- •Enough venous channel, no other contraindications to the separation and collection of white blood cells;
- •Laboratory examination: white blood cell≥3 x 10*9/L, blood platelet count≥60 x 10*/L,hemoglobin≥85g/L; lymphocyte count≥15%, total bilirubin≤100 mol/L; ALT and AST less than five times of the normal level; serum creatinine less than 1.5 times of the normal level；
- •Signed informed consent；
- •Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cells transfusion.
排除标准
- •Expected Overall survival < 6 months;
- •Patients with uncontrolled hypertension (>160/95mmHg), unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> Class II, NYHA), or myocardial infarction within 6 months.
- •Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc;
- •Other drugs, or other biological treatment,chemotherapy or radiotherapy are performed within a month.
- •Unable or unwilling to provide informed consent, or fail to comply with the test requirements.
研究组 & 干预措施
Precision Cells combined with Chemotherapy treatment:
Precision cells combined with Chemotherapy treatment: Chemotherapy: once a week with a total of six times before 60 days prior to the start of drawing blood. Precision cells：once per 3 weeks with a total of three periods.
干预措施: Chemotherapy (Drug)
Precision Cells combined with Chemotherapy treatment:
Precision cells combined with Chemotherapy treatment: Chemotherapy: once a week with a total of six times before 60 days prior to the start of drawing blood. Precision cells：once per 3 weeks with a total of three periods.
干预措施: Precision Cell Immunotherapy (Biological)
Chemotherapy
Once a week with a total of six times before 60 days prior to the start of drawing blood.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Progress-free survival
时间窗: 2 years
Quality of life
时间窗: 2 years
Questionnaire will be used.
Overall survival
时间窗: 2 years
次要结局
未报告次要终点