Image

RATS Sleeve Lobectomy After Neo-Chemo-IO for NSCLC

RATS Sleeve Lobectomy After Neo-Chemo-IO for NSCLC

Recruiting
All
Phase N/A

Powered by AI

Overview

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.

Description

Please check the details of this study on Clinicaltrials.gov

Eligibility

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.

Study details
    Stage IIB-III NSCLC
    Sleeve Lobectomy
    Robotic Surgery
    Neoadjuvant Chemoimmunotherapy

NCT07541521

Shanghai Chest Hospital

13 May 2026

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.