NCT04268108Unknown不适用
Clinical Study of Liquid Tumor Infiltrating Lymphocytes in Patients With Advanced Malignancies Resistance to Anti-PD-1 Therapy
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- the rate of reverse events
研究概览
简要总结
Safety and effectiveness of liquid tumor infiltrating lymphocytes in patients with advanced malignant tumors who have failed to anti-PD-1 therapy
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Expected lifespan is over 3 months
- •malignant tumors diagnosed by pathological examination
- •Imaging examination is at advanced stage with at least one measurable lesion
- •Ineffective or resistant to previous anti-PD-1 therapy
- •ECOG score 0-2
- •Adequate organ function
- •No other serious diseases that conflict with this protocol
- •Women of childbearing age must check for a negative blood pregnancy test within 7 days, and subjects of childbearing age must use appropriate contraception during the test and within 3 months
- •witten informed consent from the patients
排除标准
- •Severe infectious disease within 4 weeks before enrollment
- •Active hepatitis B or C virus or HIV infection
- •Severe autoimmune disease or immunodeficiency disease
- •Severe allergies
- •Severe mental disorder
- •Systematically used a large amount of glucocorticoids within 4 weeks before enrollment
- •With severe heart, liver, kidney insufficiency, diabetes and other diseases
- •Participation in other clinical studies in the past 3 months or having been treated with other gene products
结局指标
主要结局
the rate of reverse events
时间窗: three months
the rate of reverse events
次要结局
- clinical benefit rate(three months)
- time to progression(six months)
研究者
研究点 (1)
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