Comparison of the Effect of Surgical Resection Based on Lesion Extent Before and After Neoadjuvant Therapy in Patients With Stage II-IIIB Non-Small Cell Lung Cancer: A Single-Center, Real-World, Open-Label Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 354
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
This study intends to conduct a prospective, non-interventional study to compare the survival benefits of different surgical resection patterns for patients with non-small cell lung cancer who have achieved partial response (PR) after immunotherapy induction. The study plans to enroll patients suitable for surgery as assessed by radiomics evaluation and multidisciplinary team (MDT) discussion, and will assign them to the modified surgery group and the conventional surgery group based on patient preference. The resection scope in the modified surgery group is more limited compared to conventional surgery, aiming to maximize preservation of pulmonary function while ensuring oncological safety. This study will systematically evaluate the impact of different resection scopes on patient prognosis after neoadjuvant immunotherapy, providing clinical evidence for exploring individualized surgical strategies for non-small cell lung cancer in the era of immunotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed non-small cell lung cancer (NSCLC)
- •Achieved resectability after neoadjuvant immunotherapy with or without chemotherapy
- •Initially required pneumonectomy or combined lobectomy based on tumor size and extent, but became suitable for minimally invasive resection after neoadjuvant treatment
- •Age ≥ 18 years
- •ECOG performance status score of 0-1
- •Complete imaging, pathological, and follow-up data available
排除标准
- •Disease progression (PD) after neoadjuvant therapy
- •Still required pneumonectomy or combined lobectomy after neoadjuvant therapy, with no reduction in the planned surgical extent
- •Intraoperative findings indicating that R0 resection was not feasible
- •Severe cardiopulmonary dysfunction or other complications that made the patient unable to tolerate surgery
研究组 & 干预措施
Modified/Reduced Surgery Group
Under the premise of ensuring R0 resection, reduce the surgical scope, prefer composite lobectomy or lobectomy to maximize the preservation of pulmonary function.
Conventional Surgery Group
Perform a pneumonectomy or composite lobectomy within the originally planned scope
结局指标
主要结局
Disease-free survival
时间窗: Evaluate over a period of up to five years
It refers to the period from the beginning of the study until the recurrence of the disease or any cause of death.
次要结局
- Overall Survival (OS)(From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 5 years.)
- Pathological Complete Response(pCR)(up to 1 month after surgery)
- Incidence of perioperative complications(up to 1 month after surgery)