NCT05450081已完成不适用
Clinical Trials to Evaluate the Association Between the Results of Specific Genetic Tests and the Efficacy of Targeted Therapies in Patients With Non-small Cell Lung Cancer
Hunan Province Tumor Hospital1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2022年6月30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
- 140
- 试验地点
- 1
- 主要终点
- Consistency
研究概览
简要总结
Our study aimed to evaluate the correlation between test reagent specific gene test results and the efficacy of relevant targeted drugs in patients with non-small cell lung cancer, and to support the continued registration of test reagents.
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
- 否
入选标准
- •≥18，advanced non-small cell lung cancer confirmed by histopathology, and were previously or currently treated with gefitinib tablets (as the first-line treatment) or osimertinib (first-generation TKI resistance treatment) or crizotinib capsules monotherapy were evaluated for efficacy.
- •Able to provide FFPE samples with a storage life of 5 years: Large specimen 5 pieces in each case; 10 puncture specimens in each case
排除标准
- •Pathological evaluation of the tissue sample has too few tumor cells (total number of tumor cells >20%);
- •Combination therapy with chemotherapy/radiotherapy/other targeted drugs/immunotherapy drugs;
- •Maintenance treatment when the disease does not progress after other anti-tumor treatments.
结局指标
主要结局
Consistency
时间窗: October 2022-December 2022
he consistency of efficacy between specified kit and 22C3
PFS
时间窗: October 2022-December 2022
Progression free survival time
ORR
时间窗: October 2022-December 2022
Objective response rate
次要结局
未报告次要终点
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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