Safety and Feasibility of Surgery After Conversion Therapy for Locally Advanced and Advanced NSCLC

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Safety and Feasibility of Surgery After Conversion Therapy for Locally Advanced and Advanced NSCLC

Conditions
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Pulmonary Neoplasm, Advanced Cancer, Locally Advanced Cancer

Intervention / Treatment
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* Procedure: Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Volunteer to participate in the study with good compliance. Able to complete the observation and follow-up and have signed the informed consent; More than 18 years old with no limit of sex; Pathologically confirmed stage T4N0-3 or T1-3N2-3 NSCLC with residual tumor after first-line treatment (first-line chemotherapy, targeted therapy, immunotherapy, chemotherapy combined with immunotherapy, etc.) evaluated operable for radical resection; pathologically confirmed stage IVA NSCLC evaluated operable after first-line treatment (first-line chemotherapy, targeted therapy, immunotherapy, chemotherapy combined with immunotherapy, etc.); ASA score: I-III; Cardiopulmonary functions meet the requirements of radical operation for lung cancer with normal liver and kidney functions. Exclusion Criteria: Serious heart, lung, liver and kidney dysfunction and unable to tolerate the operation; Neurologic, mental illness or mental disorder which is hard to control, poor compliance, unable to cooperate or describe the treatment response; Unable to receive radical resection; Need of palliative or emergency operation due to lung abscess or hemoptysis; Having received neoadjuvant chemoradiotherapy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgery after conversion therapy<br>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. | Procedure: Surgery<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Conversion Therapy, Lung Cancer, Locally Advanced and Advanced NSCLC