Actively Recruiting
RATS Sleeve Lobectomy After Neo-Chemo-IO for NSCLC
Led by Shanghai Chest Hospital · Updated on 2026-04-21
100
Participants Needed
10
Research Sites
58 weeks
Total Duration
On this page
Sponsors
S
Shanghai Chest Hospital
Lead Sponsor
T
The Affiliated Hospital of Qingdao University
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
RATS Sleeve Lobectomy After Neo-Chemo-IO for NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6518 years
- ECOG performance status 0-2
- Histologically confirmed non-small cell lung cancer (NSCLC)
- Clinical stage IIB-III, M0, considered resectable or potentially resectable by a multidisciplinary tumor board
- Planned neoadjuvant chemoimmunotherapy including PD-1/PD-L1 inhibitor and platinum doublet chemotherapy (additional neoadjuvant thoracic radiotherapy allowed)
- Planned curative robotic-assisted thoracoscopic surgery (RATS) sleeve lobectomy with systematic lymph node dissection
- Available baseline and restaging imaging (CT with or without PET-CT)
- Ability to complete 30-day postoperative follow-up
- Ability to provide informed consent
You will not qualify if you...
- Metastatic disease (M1) at baseline or on restaging
- Neoadjuvant treatment without immunotherapy component (chemotherapy only)
- Prior systemic therapy or thoracic radiotherapy for current cancer before starting chemoimmunotherapy
- Planned palliative or non-anatomic resection (such as wedge) when sleeve lobectomy is indicated
- Clear unresectability at restaging or multidisciplinary consensus against surgery
- Contraindication to general anesthesia or high cardiopulmonary risk preventing sleeve lobectomy
- Active autoimmune disease needing systemic immunosuppression within 2 years, prior organ transplant, or history of severe pneumonitis/interstitial lung disease
- Uncontrolled infection, pregnancy, breastfeeding, or any other illness that would interfere with participation
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
2
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Actively Recruiting
3
Shenzhen People's Hospital
Shenzhen, Guangdong, China, 518020
Actively Recruiting
4
Jiangsu Cancer Institute & Hospital
Nanjing, Jiangsu, China, 210009
Actively Recruiting
5
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266000
Actively Recruiting
6
Tianjin Medical University Cancer Institute & Hospital
Tianjing, Tianjing, China, 300060
Actively Recruiting
7
Shanghai Chest Hospital, Shanghai Jiao Tong University Medicine of School
Shanghai, China, 200030
Actively Recruiting
8
Hôpital Saint Joseph Marseille
Marseille, France, 13001
Actively Recruiting
9
University Hospital, Rouen
Rouen, France, 76000
Actively Recruiting
10
Azienda Ospedaliera di Cosenza
Cosenza, Italy, 87100
Actively Recruiting
Research Team
Z
Zhigang Li, MD, PhD
CONTACT
L
Lin Huang, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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