Non-Small Cell Lung Cancer (NSCLC) Clinical Trials

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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Fujian Medical University Union Hospital
RECRUITING
Fuzhou
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
Jiangsu Cancer Institute & Hospital
RECRUITING
Nanjing
The Affiliated Hospital of Qingdao University
RECRUITING
Qingdao
Shanghai Chest Hospital, Shanghai Jiao Tong University Medicine of School
RECRUITING
Shanghai
Shenzhen People's Hospital
RECRUITING
Shenzhen
Tianjin Medical University Cancer Institute & Hospital
RECRUITING
Tianjing
France
Hôpital Saint Joseph Marseille
RECRUITING
Marseille
University Hospital, Rouen
RECRUITING
Rouen
Italy
Azienda Ospedaliera di Cosenza
RECRUITING
Cosenza
Contact Information
Primary
Zhigang Li, MD, PhD
zhigang.li@shsmu.edu.cn
0086-021-22200000
Backup
Lin Huang, MD, PhD
dr.huang.lin@shsmu.edu.cn
008618116061178
Time Frame
Start Date: 2026-04-13
Estimated Completion Date: 2027-05-30
Participants
Target number of participants: 100
Treatments
ⅡB-Ⅲ NSCLC following Neo-Chemo-IO & RATS sleeve lobectomy
All patients in this cohort will receive neoadjuvant chemo-immunotherapy (Neo-Chemo-IO) first for clinical stage IIB-III non-small cell lung cancer ( NSCLC), followed by robot-assisted thoracoscopic surgery (RATS) sleeve lobectomy.
Sponsors
Leads: Shanghai Chest Hospital
Collaborators: Shenzhen People's Hospital, Guangdong Provincial People's Hospital, Jiangsu Cancer Institute & Hospital, Fujian Medical University Union Hospital, Hopital Saint Joseph Marseille, The Affiliated Hospital of Qingdao University, Azienda Ospedaliera Cosenza, University Hospital, Rouen, Tianjin Medical University Cancer Institute and Hospital

This content was sourced from clinicaltrials.gov