RATS Sleeve Lobectomy After Neo-Chemo-IO for NSCLC

Официальное название

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

Обзор

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.

Подробное описание

Please check the details of this study on Clinicaltrials.gov

Вмешательства

• Процедура Robot-assisted thoracoscopic surgery (RATS) sleeve lobectomy
  After the neoadjuvant treatment reaches the expected effect (partial remission, complete remission, or stable disease), the patients will undergo RATS sleeve lobectomy.

Первичные конечные точки

• Unsuccessful RATS Sleeve Lobectomy [Срок оценки: From enrollment to the end of treatment at 4 weeks]

Вторичные конечные точки (9)

• Subjective Surgical Difficulty Assessment [Срок оценки: From enrollment to the end of treatment at 1 day]
• Specific Difficulty Factors [Срок оценки: From enrollment to the end of treatment at 1 day]
• Fissure Development Grade [Срок оценки: From enrollment to the end of treatment at 1 day]
• Pleural Adhesions [Срок оценки: From enrollment to the end of treatment at 1 day]
• Hilar Fibrosis [Срок оценки: From enrollment to the end of treatment at 1 day]
• Lymph Node Fusion [Срок оценки: From enrollment to the end of treatment at 1 day]
• Vascular Inflammatory Reaction / Edema [Срок оценки: From enrollment to the end of treatment at 1 day]
• Need for Proximal Vascular Control [Срок оценки: From enrollment to the end of treatment at 1 day]
• Length of stay (LOS) [Срок оценки: From enrollment to the end of treatment up to 30 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 7 центров

• Fujian Medical University Union Hospital — Фучжоу
• Guangdong Provincial People's Hospital — Гуанчжоу
• Shenzhen People's Hospital — Шэньчжэнь
• Jiangsu Cancer Institute & Hospital — Нанкин
• The Affiliated Hospital of Qingdao University — Qingdao
• Tianjin Medical University Cancer Institute & Hospital — Tianjing
• Shanghai Chest Hospital, Shanghai Jiao Tong University Medicine of School — Шанхай

Франция · 2 центра

• Hôpital Saint Joseph Marseille — Marseille
• University Hospital, Rouen — Rouen

Италия · 1 центр

• Azienda Ospedaliera di Cosenza — Cosenza

Публикации

• Chu NQ, Tan KS, Dycoco J, Adusumilli PS, Bains MS, Bott MJ, Downey RJ, Gray KD, Huang J, Isbell JM, Molena D, Sihag S, Rocco G, Jones DR, Park BJ, Rusch VW. Determinants of successful minimally invasive surgery for resectable non-small cell lung cancer after neoadjuvant therapy. J Thorac Cardiovasc Surg. 2025 Mar;169(3):753-762.e6. doi: 10.1016/j.jtcvs.2024.08.012. Epub 2024 Aug 20. PMID 39168279
• Sepesi B, Zhou N, William WN Jr, Lin HY, Leung CH, Weissferdt A, Mitchell KG, Pataer A, Walsh GL, Rice DC, Roth JA, Mehran RJ, Hofstetter WL, Antonoff MB, Rajaram R, Negrao MV, Tsao AS, Gibbons DL, Lee JJ, Heymach JV, Vaporciyan AA, Swisher SG, Cascone T. Surgical outcomes after neoadjuvant nivolumab or nivolumab with ipilimumab in patients with non-small cell lung cancer. J Thorac Cardiovasc Surg PMID 35190177
• Bott MJ, Yang SC, Park BJ, Adusumilli PS, Rusch VW, Isbell JM, Downey RJ, Brahmer JR, Battafarano R, Bush E, Chaft J, Forde PM, Jones DR, Broderick SR. Initial results of pulmonary resection after neoadjuvant nivolumab in patients with resectable non-small cell lung cancer. J Thorac Cardiovasc Surg. 2019 Jul;158(1):269-276. doi: 10.1016/j.jtcvs.2018.11.124. Epub 2018 Dec 13. PMID 30718052
• Brunelli A, Hoffman R, Wotton R, Baijal S, Bhatnagar P, Clarke K, Escriu C, Fakih O, Franks K, Lodhia J, Nardini M, Naidu B, Shackcloth M. Surgical and Pathological Results Following Neoadjuvant Nivolumab and Platinum-Based Chemotherapy for Locally Advanced Resectable NSCLC: A Multicentre Real-World Series From England. Clin Lung Cancer. 2025 May;26(3):253-261. doi: 10.1016/j.cllc.2024.12.010. Epu PMID 39818517
• Li HJ, Ding JY, Nie Q, Hong HZ, Qiu ZB, Fu R, Zhang C, Zhang JT, Xu ZY, Yang J, Zhang S, Lin JT, Yang XN, Jiang BY, Zhong WZ. Advantages of robotic-assisted thoracic surgery after neoadjuvant therapy in NSCLC: A propensity score-matched analysis. Eur J Surg Oncol. 2025 Aug;51(8):110022. doi: 10.1016/j.ejso.2025.110022. Epub 2025 Apr 7. PMID 40250266
• Mathey-Andrews C, McCarthy M, Potter AL, Beqari J, Wightman SC, Liou D, Raman V, Jeffrey Yang CF. Safety and feasibility of minimally invasive lobectomy after neoadjuvant immunotherapy for non-small cell lung cancer. J Thorac Cardiovasc Surg. 2023 Aug;166(2):347-355.e2. doi: 10.1016/j.jtcvs.2022.12.006. Epub 2022 Dec 16. PMID 36653251
• Cooper AJ, Garbo E, Arfe A, Conroy M, Shaverdian N, Bott M, Gorria T, Pecci F, Aldea M, Anagnostou V, Schoenfeld A, Gomez D, Forde PM, Awad MM, Jones DR, Ricciuti B, Chaft JE. Real-world outcomes of neoadjuvant chemoimmunotherapy in patients with nonsmall cell lung cancer: Predictors of surgery, pathologic complete response, and event-free survival. Cancer. 2025 Sep 15;131(18):e70081. doi: 10.1002 PMID 40923935
• Kneuertz PJ, Villamizar N, Altorki NK, Phillips JD, Schnorr P, Jones D, Scott S, D'Souza DM, Baiu I, Abdel-Rasoul M, Schmidt J, Nguyen DM, Merritt RE. Minimally invasive resection of non-small cell lung cancer after chemoimmunotherapy: A multicenter study in academic hospitals. J Thorac Cardiovasc Surg. 2025 Dec;170(6):1803-1812.e2. doi: 10.1016/j.jtcvs.2025.07.030. Epub 2025 Jul 25. PMID 40716726

Идентификаторы

NCT: NCT07541521 · IS26045

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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