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| Name | Class |
|---|---|
| The Affiliated Hospital of Qingdao University | OTHER |
| Fujian Medical University Union Hospital | OTHER |
| Guangdong Provincial People's Hospital | OTHER |
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The goal of this observational study is to learn whether tumor and nodal downstaging after neoadjuvant chemo-immunotherapy is associated with better surgical outcomes in patients with clinical stage IIB-III non-small cell lung cancer (NSCLC) undergoing robotic-assisted thoracic surgery. The main question it aims to answer is:
Is downstaging after neoadjuvant chemo-immunotherapy associated with better surgical outcomes in patients with stage IIB-III NSCLC undergoing robotic-assisted surgery?
Participants with resectable or potentially resectable stage IIB-III NSCLC who receive neoadjuvant chemo-immunotherapy as part of their routine clinical care and then undergo curative-intent robotic-assisted surgery will be prospectively enrolled from international centers. Clinical, operative, pathological, and postoperative outcome data will be collected, including R0 resection, the extent of resection, conversion to open surgery, postoperative complications, length of stay, readmission, and mortality.
Please check all details of this study in Clinicaltrials.gov
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| â…¡B-â…¢ NSCLC following Neo-Chemo-IO & RATS | Patients who are undergoing robotic-assisted thoracoscopic surgery for clinical stage â…¡B-â…¢ non-small cell lung cancer following neoadjuvant chemoimmunotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic-assisted surgery (RATS) | Procedure | Robotic pulmonary surgery for patients with neoadjuvant chemo-immunotherapy for stage IIB-III non-small cell lung cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete resection (R0 resection) | R0 resection (complete resection) was defined according to the International Association for the Study of Lung Cancer (IASLC) criteria as: (1) microscopically negative resection margins; (2) systematic nodal dissection including at least 6 lymph node stations (3 N1 and 3 N2, including station 7); (3) no extracapsular nodal extension; and (4) the highest mediastinal lymph node removed being negative. | From enrollment to the end of surgical treatment at 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay (LOS) | Length of stay is defined as the total number of nights from surgery to hospital discharge, calculated as the interval between the date of surgery and the date of discharge. | From enrollment to the end of the whole treatment in the index hospitalization |
| Major postoperative complications |
| Measure | Description | Time Frame |
|---|---|---|
| Days alive and out of hospital (DAOH) | DAOH is calculated as the follow-up duration minus days spent in hospital and days deceased. | From enrollment to the end of treatment at 3 months |
| Reoperation | Any unplanned surgical procedure performed during the same hospital admission or after discharge, due to postoperative complications, bleeding, infection, anastomotic leakage, or other surgical-related issues. |
Inclusion Criteria:
Exclusion Criteria:
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This study will enroll patients aged ≥18 years with clinical stage ⅡB-Ⅲ non-small cell lung cancer (NSCLC). All enrolled patients will receive neoadjuvant chemoimmunotherapy (additional neoadjuvant RT is allowed) and then undergo robotic-assisted thoracoscopic surgery (RATS).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhigang Li, MD, PhD | Contact | 0086-021-22200000 | zhigang.li@shsmu.edu.cn | |
| Lin Huang, MD, PhD | Contact | 0086-18116061178 | dr.huang.lin@shsmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Recruiting | Fuzhou | Fujian | 350001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35190177 | Background | 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. 2022 Nov;164(5):1327-1337. doi: 10.1016/j.jtcvs.2022.01.019. Epub 2022 Jan 23. | |
| 41456828 |
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| ID | Term |
|---|---|
| D065287 | Robotic Surgical Procedures |
| ID | Term |
|---|---|
| D025321 | Surgery, Computer-Assisted |
| D013514 | Surgical Procedures, Operative |
| D012371 | Robotics |
| D001331 | Automation |
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| Tianjin Medical University Cancer Institute and Hospital |
| OTHER |
| Jiangsu Cancer Institute & Hospital | OTHER |
| Shenzhen People's Hospital | OTHER |
| Hopital Saint Joseph Marseille | UNKNOWN |
| University Hospital, Rouen | OTHER |
| Azienda Ospedaliera Cosenza | OTHER |
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Major postoperative complications were defined as any complication graded as Grade III or higher according to the Clavien-Dindo classification. |
| From enrollment to the end of the whole treatment at 3 months |
| Conversion to open | Conversion to open was defined as the intraoperative switch from a robotic-assisted procedure to an open surgical procedure. | From enrollment to the end of surgical treatment |
| Extended procedures | Extended procedures refer to additional or more extensive resections/reconstructions performed beyond standard lobectomy, including but not limited to bronchial sleeve resection, vascular angioplasty, pneumonectomy, chest wall resection, and other combined procedures. | From enrollment to the end of surgical treatment |
| 30- and 90-day readmission rates | 30- and 90-day readmission rates were defined as the proportion of patients who were readmitted to any hospital within 30 days and 90 days after the initial discharge, respectively. | From enrollment to the end of treatment at 3 months |
| 30- and 90-day mortality | 30- and 90-day mortality was defined as all-cause death occurring within 30 days and 90 days after the date of surgery, respectively. | From enrollment to the end of treatment at 3 months |
| From enrollment to the end of treatment at 3 months |
| ICU admission | The requirement for postoperative admission to the intensive care unit for close monitoring, organ support, or management of severe complications. | From enrollment to the end of treatment at 3 months |
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | 510080 | China |
|
| Shenzhen People's Hospital | Recruiting | Shenzhen | Guangdong | 518020 | China |
|
| Jiangsu Cancer Institute & Hospital | Recruiting | Nanjing | Jiangsu | 210009 | China |
|
| The Affiliated Hospital of Qingdao University | Recruiting | Qingdao | Shandong | 266000 | China |
|
| Tianjin Medical University Cancer Institute & Hospital | Recruiting | Tianjing | Tianjing | 300060 | China |
|
| Shanghai Chest Hospital, Shanghai Jiao Tong University Medicine of School | Recruiting | Shanghai | 200030 | China |
|
| Hôpital Saint Joseph Marseille | Recruiting | Marseille | 13001 | France |
|
| University Hospital, Rouen | Recruiting | Rouen | 76000 | France |
|
| Azienda Ospedaliera di Cosenza | Recruiting | Cosenza | 87100 | Italy |
|
| Background |
| Li X, Li Q, Zhao E, Yang F, Gao E, Lin L, Li Y, Hu X, Zhu Y, Zhao D, Fan J, Song X, Duan L. Perioperative Outcomes of Robotic- vs Video-Assisted Thoracoscopic Surgery in Non-Small Cell Lung Cancer After Neoadjuvant Therapy. Ann Thorac Surg. 2026 May;121(5):1184-1193. doi: 10.1016/j.athoracsur.2025.12.003. Epub 2025 Dec 26. |
| 36509569 | Background | Herrera LJ, Schumacher LY, Hartwig MG, Bakhos CT, Reddy RM, Vallieres E, Kent MS. Pulmonary Open, Robotic, and Thoracoscopic Lobectomy study: Outcomes and risk factors of conversion during minimally invasive lobectomy. J Thorac Cardiovasc Surg. 2023 Jul;166(1):251-262.e3. doi: 10.1016/j.jtcvs.2022.10.050. Epub 2022 Nov 15. |
| 30718052 | Background | 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. |
| 29718155 | Background | Veronesi G, Park B, Cerfolio R, Dylewski M, Toker A, Fontaine JP, Hanna WC, Morenghi E, Novellis P, Velez-Cubian FO, Amaral MH, Dieci E, Alloisio M, Toloza EM. Robotic resection of Stage III lung cancer: an international retrospective study. Eur J Cardiothorac Surg. 2018 Nov 1;54(5):912-919. doi: 10.1093/ejcts/ezy166. |
| 40716726 | Background | 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. |
| 40619176 | Background | Hawkins A, Martin LW. Operative Challenges After Induction Immunotherapy for Lung Cancer. Thorac Surg Clin. 2025 Aug;35(3):285-298. doi: 10.1016/j.thorsurg.2025.04.002. Epub 2025 Jun 6. |
| 40002233 | Background | Trabalza Marinucci B, Mancini M, Siciliani A, Messa F, Piccioni G, D'Andrilli A, Maurizi G, Ciccone AM, Menna C, Vanni C, Tiracorrendo M, Rendina EA, Ibrahim M. Surgical Techniques for Non-Small-Cell Lung Cancer After Neoadjuvant Chemo-Immunotherapy: State of Art and Review of the Literature. Cancers (Basel). 2025 Feb 14;17(4):638. doi: 10.3390/cancers17040638. |
| 40917729 | Background | Liu W, Tang J, Li X, Gong L, Yang D, Yin H, Wang W, Zhang B. Reduction in surgical scope after neoadjuvant chemotherapy and immunotherapy for non-small cell lung cancer. Oncol Lett. 2025 Aug 27;30(5):501. doi: 10.3892/ol.2025.15247. eCollection 2025 Nov. |
| 40923935 | Background | 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/cncr.70081. |
| 38512301 | Background | Sorin M, Prosty C, Ghaleb L, Nie K, Katergi K, Shahzad MH, Dube LR, Atallah A, Swaby A, Dankner M, Crump T, Walsh LA, Fiset PO, Sepesi B, Forde PM, Cascone T, Provencio M, Spicer JD. Neoadjuvant Chemoimmunotherapy for NSCLC: A Systematic Review and Meta-Analysis. JAMA Oncol. 2024 May 1;10(5):621-633. doi: 10.1001/jamaoncol.2024.0057. |
| 35403841 | Background | Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N; CheckMate 816 Investigators. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985. doi: 10.1056/NEJMoa2202170. Epub 2022 Apr 11. |
| 39817679 | Background | Siegel RL, Kratzer TB, Giaquinto AN, Sung H, Jemal A. Cancer statistics, 2025. CA Cancer J Clin. 2025 Jan-Feb;75(1):10-45. doi: 10.3322/caac.21871. Epub 2025 Jan 16. |
| D013672 |
| Technology |
| D013676 | Technology, Industry, and Agriculture |