Lung CancerNCT07135856
Sleeve Lobectomy Following Neoadjuvant Therapy in NSCLC
An observational study of Lung Cancer and Neoadjuvant Therapy, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Neoadjuvant Therapy
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will involve multiple thoracic surgery centers with experience in advanced surgical techniques for lung cancer, including sleeve resections and neoadjuvant management. Each center will contribute anonymized data from eligible cases, in accordance with local ethical approvals and data protection regulations.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200000
Xinghua Cheng, M.D., Ph.D., 86+17701681215, chengxinghua_001@163.com
Zhebing Lin, M.D., 86+18957727196, lzb0315@sjtu.edu.cn
About this study
Official title: Comparative Analysis of Minimally Invasive and Open Sleeve Lobectomy Following Neoadjuvant Therapy in NSCLC: A Multicenter Retrospective Evaluation of Surgical Outcomes
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.
- Conditions
- Lung Cancer, Neoadjuvant Therapy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Thoracotomy sleeve lobectomy | Patients who underwent open sleeve lobectomy following neoadjuvant therapy | |
| MIS sleeve lobectomy | Patients who underwent minimally invasive (i.e. VATS and RATS) sleeve lobectomy following neoadjuvant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year RFS
In this study, the investigators will focus on the 3-year recurrence-free survival (RFS) of the participants between the two groups (open vs. MIS) for the comparison of the long-term oncologic outcomes, as the primary outcome.
Measured: 3 years
Secondary outcomes (1)
3-year OS
The investigators will also focus on the 3-year overall survival (OS) of the participants between the two groups (open vs. MIS) for the comparison of the long-term oncologic outcomes, as the secondary outcome.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Sep 2025
- Primary completion1 Nov 2025
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, University of Padova
- Responsible party
- Principal investigator, Xinghua Cheng, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135856
- Sponsor's protocol ID
- ShanghaiChestNeoSleeve
- Status last verified
- Jul 2025
- First submitted
- 8 Aug 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Minimally Invasive and Open Sleeve Lobectomy Following Neoadjuvant Therapy in NSCLC: A Multicenter Retrospective Evaluation of Surgical Outcomes
- ClinicalTrials.gov ID
- NCT07135856
- Acronym / sponsor ID
- ShanghaiChestNeoSleeve
- Conditions
- Lung Cancer, Neoadjuvant Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, University of Padova
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracotomy sleeve lobectomy | – | –Patients who underwent open sleeve lobectomy following neoadjuvant therapy |
| MIS sleeve lobectomy | – | –Patients who underwent minimally invasive (i.e. VATS and RATS) sleeve lobectomy following neoadjuvant therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will involve multiple thoracic surgery centers with experience in advanced surgical techniques for lung cancer, including sleeve resections and neoadjuvant management. Each center will contribute anonymized data from eligible cases, in accordance with local ethical approvals and data protection regulations.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
3-year RFS
Time frame: 3 years
In this study, the investigators will focus on the 3-year recurrence-free survival (RFS) of the participants between the two groups (open vs. MIS) for the comparison of the long-term oncologic outcomes, as the primary outcome.
1 secondary outcome
3-year OS
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Neoadjuvant Therapy, run by Shanghai Chest Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinghua Cheng, M.D., Ph.D. (86+17701681215, chengxinghua_001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year RFS (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.