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Sleeve Lobectomy Following Neoadjuvant Therapy in NSCLC

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Enrolling

Conditions

Lung Cancer
Neoadjuvant Therapy

Study type

Observational

Funder types

Other

Identifiers

NCT07135856
ShanghaiChestNeoSleeve

Details and patient eligibility

About

The goal of this observational, retrospective, multicenter cohort study is to evaluate the surgical and oncologic outcomes of sleeve lobectomy performed via minimally invasive (RATS/VATS) or open thoracotomy approaches in patients with non-small cell lung cancer (NSCLC) who have undergone neoadjuvant therapy, including chemotherapy, immunotherapy, or combination regimens. The main questions this study aims to answer are:

  • Does minimally invasive sleeve lobectomy result in comparable or improved perioperative and postoperative outcomes compared to open thoracotomy following neoadjuvant treatment in NSCLC?
  • Does surgical approach influence oncologic endpoints such as margin status, lymph node dissection, recurrence-free survival, and overall survival? This research addresses a critical gap in the thoracic oncology field by evaluating the safety, complexity, and efficacy of advanced surgical techniques in the context of evolving multimodal therapy paradigm. Findings may inform clinical decision-making and optimize patient selection in an era of increasing use of neoadjuvant strategies for resectable NSCLC.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≥ 18 years
  • Histologically confirmed NSCLC
  • Undergoing sleeve lobectomy with curative intent
  • Receipt of neoadjuvant therapy (chemotherapy, immunotherapy, target therapy, etc.)
  • Surgical approach: either minimally invasive (VATS or RATS) or open thoracotomy
  • Availability of complete perioperative and follow-up data (minimum 12-month follow-up or until death)
  • Signed informative consent

Exclusion criteria

  • Sublobar resections (e.g., segmentectomy) or pneumonectomy
  • Absence of neoadjuvant therapy
  • Purely diagnostic surgical procedures
  • Incomplete medical records or lost to follow-up
  • Metastatic (stage IV) disease at time of surgery

Trial design

400 participants in 2 patient groups

Thoracotomy sleeve lobectomy
Description:
Patients who underwent open sleeve lobectomy following neoadjuvant therapy
MIS sleeve lobectomy
Description:
Patients who underwent minimally invasive (i.e. VATS and RATS) sleeve lobectomy following neoadjuvant therapy

Trial contacts and locations

1

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Central trial contact

Xinghua Cheng, M.D., Ph.D.; Zhebing Lin, M.D.

Data sourced from clinicaltrials.gov

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