RecruitingNCT07541521

RATS Sleeve Lobectomy After Neo-Chemo-IO for NSCLC

Robotic-Assisted Sleeve Lobectomy for Non-Small Cell Lung Cancer After Neoadjuvant Chemoimmunotherapy


Sponsor

Shanghai Chest Hospital

Enrollment

100 participants

Start Date

Apr 13, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Inclusion Criteria9

  • 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 Criteria8

  • 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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Interventions

PROCEDURERobot-assisted thoracoscopic surgery (RATS) sleeve lobectomy

After the neoadjuvant treatment reaches the expected effect (partial remission, complete remission, or stable disease), the patients will undergo RATS sleeve lobectomy.


Locations(10)

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

Shanghai Chest Hospital, Shanghai Jiao Tong University Medicine of School

Shanghai, China

Hôpital Saint Joseph Marseille

Marseille, France

University Hospital, Rouen

Rouen, France

Azienda Ospedaliera di Cosenza

Cosenza, Italy

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NCT07541521


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