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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Ruijin hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, China
perioperative morbidity
rate of perioperative complications, mainly include: pneumonia, arrhythmia, incision infection, vocal cord paralysis, trachea cannula
Time frame: postoperative in-hospital stay up to 30 days
lymph nodes counts
overall lymph node counts, number of stations dissected, and number of lymph nodes in each lymph node station
Time frame: At operation day
R0 rate
R0 resection rate
Time frame: postoperative in-hospital stay up to 30 days
operation time
duration of operation
Time frame: At operation day
blood loss
blood loss in the operation
Time frame: At operation day
operative complications
rate of adverse events happened in the operation
Time frame: At operation day
postoperative hospital stay
length of postoperative hospitalization
Time frame: postoperative in-hospital stay up to 30 days
30-day mortality
30-day mortality after surgery
Time frame: postoperative in-hospital stay up to 30 days
1-year overall survival (OS)
OS at 1 year after surgery
Time frame: 1 year after surgery
3-year overall survival (OS)
OS at 3 year after surgery
Time frame: 3 year after surgery
1-year disease-free survival (DFS)
DFS at 1 year after surgery
Time frame: 1 year after surgery
3-year disease-free survival (DFS)
DFS at 3 years after surgery
Time frame: 3 year after surgery
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