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RATS Sleeve Lobectomy After Neo-Chemo-IO for NSCLC

Recruitingn/aAges any - anyAllShanghai Chest Hospital
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In plain words

What the trial is, and whether it could suit you

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 w

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📋 Eligibility rules (as published)
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.
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What it tests

  • Robot-assisted thoracoscopic surgery (RATS) sleeve lobectomy
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Where

10 sites
Fujian Medical University Union Hospital
Fuzhou, China
Guangdong Provincial People's Hospital
Guangzhou, China
Shenzhen People's Hospital
Shenzhen, China
Jiangsu Cancer Institute & Hospital
Nanjing, China
The Affiliated Hospital of Qingdao University
Qingdao, China
Tianjin Medical University Cancer Institute & Hospital
Tianjing, China
Shanghai Chest Hospital, Shanghai Jiao Tong University Medicine of School
Shanghai, China
Hôpital Saint Joseph Marseille
Marseille, France

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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