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临床试验/NCT05637580
NCT05637580已完成不适用

Real-world Analysis of Pathological Tumor and Lymph Node Responses After Neoadjuvant Immunochemotherapy in Initially-unresectable Non-small Cell Lung Cancer

Guangdong Provincial People's Hospital1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2019年5月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
1
主要终点
Event-free survival

研究概览

简要总结

This is a real-world study with the largest sample size investigating the pathological tumor and lymph node responses to neoadjuvant immunochemotherapy in non-small cell lung cancer to date. Patients with initially unresectable NSCLC underwent immunochemotherapy and response to treatment was assessed after every two treatment cycles. Clinicopathologic features of patients including epidemiological data, clinical manifestations, operation strategies, pathological findings, and prognostic information were recorded and evaluated.

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

入选标准

  • Patients with stage III NSCLC who received neoadjuvant immunochemotherapy.
  • early-stage NSCLC patients who were initially unresectable.
  • 18 years of age or older.
  • Karnofsky performance status (KPS) score of 100 or 90.

排除标准

  • Patients with stage IV NSCLC
  • Patients with known ALK translocations or EGFR mutations.
  • Karnofsky performance status (KPS) score <90.

研究组 & 干预措施

combined well responder

Both primary tumor and nodal response achieve major pathological response (MPR).

干预措施: Timing of drug administration (Drug)

poor responder

Primary tumor or/and nodal response can not achieve MPR.

干预措施: Timing of drug administration (Drug)

结局指标

主要结局

Event-free survival

时间窗: At least one year

the time from diagnosis to any progression of disease precluding surgery, progression or recurrence of disease after surgery or death from any cause.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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