Actively Recruiting

All Genders
NCT07541521

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

All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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