Preoperative ROS1-TKI Therapy for ROS1 Fusion-Positive Locally Advanced Lung Adenocarcinoma: A Multicenter Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Major pathological response rate
研究概览
简要总结
This multicenter retrospective study evaluates preoperative ROS1-TKI therapy in patients with ROS1 fusion-positive locally advanced lung adenocarcinoma. Patients who received ROS1-TKI therapy before surgical resection were retrospectively identified from four tertiary hospitals in China. The study describes clinicopathological characteristics, radiographic response, treatment-related adverse events, surgical outcomes, pathological response, and follow-up outcomes.
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
- •Age 18 years or older.
- •Histologically confirmed lung adenocarcinoma.
- •ROS1 fusion positivity confirmed in tumor tissue at the DNA or RNA level.
- •M0 disease at baseline.
- •Receipt of targeted therapy before surgery.
- •Surgical resection performed after ROS1-TKI therapy.
- •Availability of comprehensive clinical, radiographic, treatment, surgical, pathological, and follow-up data.
排除标准
- •Baseline M1 disease.
- •Receipt of radiotherapy or immunotherapy before ROS1-TKI therapy.
- •No surgical resection after ROS1-TKI therapy.
- •Lack of essential data for endpoint evaluation.
研究组 & 干预措施
Preoperative ROS1-TKI Therapy Cohort
Patients with ROS1 fusion-positive locally advanced lung adenocarcinoma who received ROS1-TKI therapy before surgical resection.
干预措施: ROS1-TKI Therapy (Drug)
结局指标
主要结局
Major pathological response rate
时间窗: At the time of surgical resection after preoperative ROS1-TKI therapy
Proportion of patients with 10% or fewer residual viable tumor cells in the resected primary tumor.
Major pathological response rate
时间窗: At surgical resection
Proportion of patients with 10% or fewer residual viable tumor cells in the resected primary tumor.
次要结局
未报告次要终点
研究者
Wu Nan
Professor
Peking University Cancer Hospital & Institute