Effects of Neoadjuvant Immunotherapy on Patients With Lung Cancer: a Prospective, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Event-free survival
研究概览
简要总结
The goal of this observational study is to learn about the long-term effects of neoadjuvant immunotherapy in patients with lung cancer. The main questions it aims to answer are:
- Does pneumonectomy bring more benefits for pateints than lobectomy?
- Does surgery bring more benefits for patients than non-surgery modalities (such as radiotherapy) after neoadjuvnat immunotherapy? Participants will receive neoadjuvant treatment and the study will analyze the data.
详细描述
This observational study aims to comprehensively evaluate the effectiveness and long-term clinical outcomes of neoadjuvant treatment in patients with lung cancer. Central to this investigation are two key questions: ·Does pneumonectomy bring more benefits for pateints than lobectomy?
- Does surgery bring more benefits for patients than non-surgery modalities (such as radiotherapy) after neoadjuvnat immunotherapy? Participants will receive neoadjuvant treatment, and through rigorous analysis of data, this study endeavors to provide nuanced insights into these fundamental queries, fostering advancements in clinical decision-making and patient management strategies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 79 years;
- •Received at least two cycles of neoadjuvant immunotherapy;
- •ECOG performance status score of 0;
- •Complete clinical information including imaging data available.
排除标准
- •Diagnosed with or suspected active autoimmune diseases;
- •Presence of EGFR/ALK sensitive mutations;
- •Pregnant or breastfeeding women;
- •Previous anti-tumor therapies including chemotherapy or radiotherapy;
- •History of organ transplantation or hematopoietic stem cell transplantation;
- •Interstitial pneumonia, pulmonary fibrosis, or severe emphysema;
- •Uncontrolled diabetes mellitus;
- •Uncontrolled hypertension.
研究组 & 干预措施
Surgery
Patients will undergo surgery after neoadjuvant immunotherapy.
干预措施: Pneumonectomy (Procedure)
Surgery
Patients will undergo surgery after neoadjuvant immunotherapy.
干预措施: lobectomy (Procedure)
Non-surgery
Patients will receive non-surgical treatment after neoadjuvant treatment.
干预措施: radiotherapy (Radiation)
Non-surgery
Patients will receive non-surgical treatment after neoadjuvant treatment.
干预措施: Anti-Tumor Drugs (Drug)
结局指标
主要结局
Event-free survival
时间窗: Event-free survival was defined as the time from neoadjuvant treatment to metastasis or death by any cause in the absence of metastasis, up to approximately 10 years.
次要结局
- Overall survival(From date of neoadjuvant treatment until date of death due to any cause, up to approximately 10 years.)
- Perioperative Complication rate(Within 6 months after neoadjuvant treatment.)