NCT07541521Recruiting
RATS Sleeve Lobectomy After Neo-Chemo-IO for NSCLC
Robotic-Assisted Sleeve Lobectomy for Non-Small Cell Lung Cancer After Neoadjuvant Chemoimmunotherapy
Source: ClinicalTrials.gov · Last updated 21 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 8 Apr 2026
- Start date
- Apr 2026
- Primary completion date
- May 2027
- Lead sponsor
- Shanghai Chest Hospital
- Diseases
- Lung cancer, Childhood cancers
- NCT number
- NCT07541521
What you commit to
- Study type: Observational
- Planned participants: 100
- From Apr 2026 to the primary completion date, May 2027
- 10 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Active autoimmune disease requiring systemic immunosuppression within 2 years, prior organ transplant, or history of grade ≥2 pneumonitis/ILD
Other illness
- Metastatic disease (M1) at baseline or on restaging.
- Uncontrolled infection, pregnancy or breastfeeding, or any intercurrent illness that would compromise participation.
Other
- Contraindication to general anesthesia or prohibitive cardiopulmonary risk precluding sleeve/lobectomy.
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| Guangdong Provincial People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Jiangsu Cancer Institute & Hospital Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| The Affiliated Hospital of Qingdao University Coordinator of this site? Confirm its status | Qingdao | China | Recruiting |
| Shanghai Chest Hospital, Shanghai Jiao Tong University Medicine of School Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shenzhen People's Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
| Tianjin Medical University Cancer Institute & Hospital Coordinator of this site? Confirm its status | Tianjing | China | Recruiting |
| Hôpital Saint Joseph Marseille Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| University Hospital, Rouen Coordinator of this site? Confirm its status | Rouen | France | Recruiting |
| Azienda Ospedaliera di Cosenza Coordinator of this site? Confirm its status | Cosenza | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.