RATS Sleeve Lobectomy After Neo-Chemo-IO for NSCLC
Recruiting · NCT07541521 · Observational (researchers observe without assigning treatment) · Lead sponsor: Shanghai Chest Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- 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.
Where it is running
10 locations listed.
- Azienda Ospedaliera di Cosenza - Cosenza, Italy
- Hôpital Saint Joseph Marseille - Marseille, France
- University Hospital, Rouen - Rouen, France
- Shanghai Chest Hospital, Shanghai Jiao Tong University Medicine of School - Shanghai, China
- Fujian Medical University Union Hospital - Fuzhou, Fujian, China
- Guangdong Provincial People's Hospital - Guangzhou, Guangdong, China
- Shenzhen People's Hospital - Shenzhen, Guangdong, China
- Jiangsu Cancer Institute & Hospital - Nanjing, Jiangsu, China
- The Affiliated Hospital of Qingdao University - Qingdao, Shandong, China
- Tianjin Medical University Cancer Institute & Hospital - Tianjing, Tianjing, China