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Lung cancer is one of the most common malignant tumors worldwide and the mortality ranks first in the world. In recent years, with the development of targeted therapy and immunotherapy, the overall survival of lung cancer patients has improved significantly. However, the inoperable advanced tumor remains the main reason for the poor prognosis of lung cancer. Thus, we aim to carry out this single-arm, prospective study to evaluate the safety and feasibility of surgery after conversion therapy for locally advanced and advanced non-small cell lung cancer.
Previous studies have shown that selective surgery after conversion therapy is feasible and safe in locally advanced or stage IV patients, and indicates potential benefits for these patients. However, surgery after conversion therapy is difficult and has high risk of postoperative complications which requires strict operation indications and patient screening. At present, there are only relevant retrospective studies and no prospective evidence. Therefore, our team plans to carry out this single-arm prospective clinical trial to evaluate the safety and feasibility of surgery in patients with locally advanced and advanced non-small cell lung cancer after conversion therapy, so as to lay the foundation for further research and clinical application.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery after conversion therapy | Experimental | Participants with locally advanced or advanced NSCLC who received first-line treatment have been evaluated as resectable after multidisciplinary discussion involving the department of thoracic surgery, respiratory medicine, radiology and oncology. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery | Procedure | Participants having been evaluated as operable after receiving first-line treatment (first-line chemotherapy, targeted therapy, immunotherapy, chemotherapy combined with immunotherapy, etc.) will receive surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| perioperative morbidity | rate of perioperative complications, mainly include: pneumonia, arrhythmia, incision infection, vocal cord paralysis, trachea cannula | postoperative in-hospital stay up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| lymph nodes counts | overall lymph node counts, number of stations dissected, and number of lymph nodes in each lymph node station | At operation day |
| R0 rate | R0 resection rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| He-Cheng Li, doctor | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin hospital, Shanghai JiaoTong University School of Medicine | Shanghai | Shanghai Municipality | 021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41880079 | Derived | Yan Y, Han Y, Niu Z, Zhang X, Li C, Cao Y, Yin Z, Zhu L, Hang J, Che J, Ren J, Xiang J, Chen K, Du H, Han D, Yang X, Zhang Y, Chen X, Jing H, Yu S, Wang X, Guo Z, Chen X, Luo F, Zhong W, Jin R, Li H. Conversion Surgery After Induction Therapy for Initially Unresectable Stage III Non-small Cell Lung Cancer: A Proof-of-Concept Trial. Ann Surg Oncol. 2026 Jul;33(7):6242-6251. doi: 10.1245/s10434-026-19461-z. Epub 2026 Mar 25. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| postoperative in-hospital stay up to 30 days |
| operation time | duration of operation | At operation day |
| blood loss | blood loss in the operation | At operation day |
| operative complications | rate of adverse events happened in the operation | At operation day |
| postoperative hospital stay | length of postoperative hospitalization | postoperative in-hospital stay up to 30 days |
| 30-day mortality | 30-day mortality after surgery | postoperative in-hospital stay up to 30 days |
| 1-year overall survival (OS) | OS at 1 year after surgery | 1 year after surgery |
| 3-year overall survival (OS) | OS at 3 year after surgery | 3 year after surgery |
| 1-year disease-free survival (DFS) | DFS at 1 year after surgery | 1 year after surgery |
| 3-year disease-free survival (DFS) | DFS at 3 years after surgery | 3 year after surgery |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |