NCT05129462已完成不适用
Consistency of Immunohistochemical Detecting Assays Using E1L3N and 22C3 Monoclonal Antibodies for Detection of PD-L1 Expression in NSCLC Patients: A Prospective CONFIDENCE Study
Hunan Province Tumor Hospital1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2018年8月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Consistency
研究概览
简要总结
Evaluated the correlation between the qualitative test results of Xiamen Aide PD-L1 antibody reagent (immunohistochemistry) and the efficacy of Keytruda single-agent therapy, and the research data is used to support the registration and marketing of the assessment reagent
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥18，advanced non-small cell lung cancer confirmed by histopathology, and have received K-drug mono-therapy in the past, the return visit information is complete, with traceable information such as tumor imaging examinations before and after treatment, and the curative effect can be judged;
- •Able to provide FFPE samples with a storage life of 4 years: 6 slices of continuous slices with a thickness of 3-5μm
排除标准
- •Pathological evaluation of the tissue sample has too few tumor cells (total number of tumor cells <100);
- •K-drug mono-therapy is neoadjuvant therapy or adjuvant therapy;
- •Other situations that the investigator thinks are not suitable for participating in this clinical study
结局指标
主要结局
Consistency
时间窗: August 2018- September 2021
the consistency of PD-L1 expression between monoclonal antibodies of E1L3N and 22C3
次要结局
- PFS(August 2018- September 2021)
- ORR(August 2018- September 2021)
研究者
Yongchang Zhang
Director, Head of Medical Oncology, Principal Investigator, Clinical Professor
Hunan Province Tumor Hospital
研究点 (1)
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