Robotic-Assisted Sleeve Lobectomy for Non-Small Cell Lung Cancer After Neoadjuvant Chemoimmunotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- Unsuccessful RATS Sleeve Lobectomy
研究概览
简要总结
The goal of this multicenter prospective observational study is to learn about the surgical difficulty and outcomes of robotic-assisted sleeve lobectomy in patients with non-small cell lung cancer (NSCLC) after neoadjuvant chemoimmunotherapy. The main questions it aims to answer are:
What is the rate of unsuccessful robotic-assisted sleeve lobectomy after neoadjuvant chemoimmunotherapy?
What factors are associated with unsuccessful surgery?
How do surgeons subjectively assess intraoperative difficulty across multiple dimensions during these procedures?
In this study, unsuccessful surgery is defined as any of the following: conversion to thoracotomy, incomplete (non-R0) resection, or major postoperative complications. Participants who are scheduled to undergo curative-intent robotic-assisted sleeve lobectomy as part of their routine clinical care after neoadjuvant chemoimmunotherapy will be enrolled from multiple centers. Clinical, intraoperative, pathological, and short-term postoperative data will be collected prospectively. In addition, surgeons will be asked to provide a multidimensional subjective assessment of intraoperative difficulty, including factors such as pleural adhesions, hilar fibrosis, nodal matting, fissure completeness, and vascular inflammation or edema, to better characterize the technical challenges of surgery and their association with perioperative outcomes.
详细描述
Please check the details of this study on Clinicaltrials.gov
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •ECOG performance status 0-2
- •Histologically confirmed NSCLC
- •AJCC 9th clinical stage IIB-III, M0, deemed resectable or potentially resectable by the multidisciplinary tumour discussion (MDT)
- •Planned neoadjuvant chemo-immunotherapy (PD-1/PD-L1 inhibitor + platinum doublet；additional neoadjuvant thoracic radiotherapy is allowed)
- •Planned curative-intent RATS sleeve lobectomy with systematic nodal dissection
- •Baseline and restaging imaging per protocol (CT ± PET-CT)
- •Complete 30-day postoperative follow-up
- •Ability to provide informed consent
排除标准
- •Metastatic disease (M1) at baseline or on restaging.
- •No immunotherapy component in neoadjuvant regimen (pure chemotherapy) .
- •Prior systemic therapy or thoracic radiotherapy for the current cancer before starting chemo-IO.
- •Palliative intent or planned non-anatomic resection only (e.g., wedge) when sleeve/lobectomy is indicated oncologically.
- •Clear unresectability at restaging (e.g., multistation bulky N2/N3 not responding; unreconstructable T4 invasion) or MDT consensus against surgery.
- •Contraindication to general anesthesia or prohibitive cardiopulmonary risk precluding sleeve/lobectomy.
- •Active autoimmune disease requiring systemic immunosuppression within 2 years, prior organ transplant, or history of grade ≥2 pneumonitis/ILD
- •Uncontrolled infection, pregnancy or breastfeeding, or any intercurrent illness that would compromise participation.
研究组 & 干预措施
ⅡB-Ⅲ NSCLC following Neo-Chemo-IO & RATS sleeve lobectomy
All patients in this cohort will receive neoadjuvant chemo-immunotherapy (Neo-Chemo-IO) first for clinical stage IIB-III non-small cell lung cancer ( NSCLC), followed by robot-assisted thoracoscopic surgery (RATS) sleeve lobectomy.
干预措施: Robot-assisted thoracoscopic surgery (RATS) sleeve lobectomy (Procedure)
结局指标
主要结局
Unsuccessful RATS Sleeve Lobectomy
时间窗: From enrollment to the end of treatment at 4 weeks
The unsuccessful RATS sleeve lobectomy after neoadjuvant chemo-immunotherapy for NSCLC, defined as conversion to thoracotomy, non-R0 resection, or Clavien-Dindo grade ≥ III postoperative complications.
次要结局
- Subjective Surgical Difficulty Assessment(From enrollment to the end of treatment at 1 day)
- Specific Difficulty Factors(From enrollment to the end of treatment at 1 day)
- Fissure Development Grade(From enrollment to the end of treatment at 1 day)
- Need for Proximal Vascular Control(From enrollment to the end of treatment at 1 day)
- Pleural Adhesions(From enrollment to the end of treatment at 1 day)
- Hilar Fibrosis(From enrollment to the end of treatment at 1 day)
- Lymph Node Fusion(From enrollment to the end of treatment at 1 day)
- Vascular Inflammatory Reaction / Edema(From enrollment to the end of treatment at 1 day)
- Length of stay (LOS)(From enrollment to the end of treatment up to 30 days)
研究者
Zhigang Li
Professor, MD, PhD
Shanghai Chest Hospital