跳至主要内容
临床试验/NCT06131645
NCT06131645已完成不适用

The IASLC Grading System as a Predictor for EGFR-TKI Therapy in EGFR-mutant Lung Adenocarcinoma

Fudan University1 个研究点 分布在 1 个国家目标入组 2,160 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,160
试验地点
1
主要终点
Progression-free survival

研究概览

简要总结

The investigators previously validated the grading system proposed by International Association for the Study of Lung Cancer (IASLC) for invasive nonmucinous lung adenocarcinoma (LADC) for its reproducibility, prognostication function and predictive value of adjuvant chemotherapy (ACT). In this exploratory study, the investigators aimed to investigate the role of IASLC grading system in EGFR tyrosine kinase inhibitor (TKI) therapy selection either as adjuvant or palliative therapy.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • invasive lung adenocarcinoma patients who underwent complete resection with positive EGFR mutations in exons 18-21.

排除标准

  • adenocarcinoma in situ (AIS), minimally invasive adenocarcinoma (MIA), invasive mucinous adenocarcinoma and other variants of adenocarcinoma
  • patients with pathologic slides unavailable for re-evaluation

结局指标

主要结局

Progression-free survival

时间窗: 5 years

PFS was defined as time from initiation of systemic palliative treatment to date of disease progression or death for 1L treatment of each patient and the initiation time was re-assigned additionally for each drug applied during the treatment history of the patients regardless of line of therapy (all lines)

Disease-free survival

时间窗: 5 years

DFS was defined as time from initiation of surgery to date of first event (recurrence or death)

次要结局

  • Overall survival(5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Haiquan Chen

Director in the Department of Thoracic Surgery, FUSCC

Fudan University

研究点 (1)

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