Surgical Strategy of NSCLC Patients After Neo-adjuvant or Induction Treatment
NCT Number: NCT06534489
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Non-small Cell Lung Cancer|Surgery
Interventions: PROCEDURE: neoadjuvant immuno-chemotherapy and surgery
Sponsor: Ruijin Hospital
Collaborators: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine|Huadong Hospital|Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-08-31
Completion Date: 2029-08-31
Locations: Ruijin hospital, Shanghai, 200025, China

Summary:
Lung cancer is one of the most common malignant tumors worldwide and has the highest mortality rate among malignant tumors. In recent years, with the gradual development of therapeutic modalities such as targeted therapy and immunotherapy, the overall survival of lung cancer patients has improved significantly. However, late tumor staging at the time of diagnosis often leaves patients with only pneumonectomy, which affects the prognosis with a higher rate of postoperative complications than lobectomy, poorer quality of life and the possible loss of the opportunity to continue adjuvant therapy. Our group proposes to conduct this single-arm prospective clinical study to investigate the feasibility, safety and prognosis of the conversion from pneumonectomy to lobectomy after neoadjuvant or induction therapy in patients with operable non-small cell lung cancer.

Primary Outcome Measures: Tumor R0 resection rate (lobectomy), the proportion of patients with complete tumor removal by lobectomy, as evaluated by the pathologic findings of postoperative lung cancer specimens, Two weeks after surgery according to Frozen pathologic test and Paraffin pathologic test
Secondary Outcome Measures: Lymph node dissection, Record the total number of lymph node dissection, the number of stations of lymph node dissection, and the number of lymph node dissection at each station during the operation,and evaluate them according to the pathologic results., Two weeks after surgery according to Paraffin pathologic test|Duration of surgery, Record the duration of surgery in minute（min），evaluated by surgical records and perioperative clinical manifestations, laboratory tests, physical examination, 1 month after surgery|Intraoperative bleeding, Record intraoperative bleeding in milliliter （ml）, evaluated by surgical records and perioperative clinical manifestations, laboratory tests, physical examination, 1 month after surgery|Incidence of intraoperative accidents, Record the incidence of intraoperative accidents in rate（%）, including bleeding，injury to normal tissue or organ， evaluated by surgical records and perioperative clinical manifestations, laboratory tests, physical examination, 1 month after surgery|Postoperative short-term efficacy indicators, record the length of postoperative hospitalization (days), survival within 30 days after surgery, and evaluate through postoperative follow-up, 1 month after surgery|Perioperative complication rate, Evaluated by clinical manifestations, laboratory tests, and physical examination, 1 month after surgery|3-year disease-free survival rate, defined as the proportion of patients without tumor recurrence or metastasis 3 years after surgery, evaluated by postoperative follow-up, When all enrolled patients complete 3-year follow-up|3-year overall survival rate, defined as the proportion of patients who are still alive 3 years after surgery, and evaluated by postoperative follow-up., When all enrolled patients complete 3-year follow-up