Lung cancer
Conditions
Interventions
Robot-Assisted Surgery Group:Robot-Assisted Surgery
Video-Assisted Thoracoscopic Surgery Group:Video-Assisted Thoracoscopic Surgery
Sponsors
Shenzhen People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 - 75 years old, gender not restricted; 2. Pathologically diagnosed as NSCLC, meeting the above diagnostic criteria; 3. AJCC 9th edition clinical stage IIB-III (M0), MDT assessment indicates resectable or potentially resectable; 4. Completed 2 - 4 cycles of immunotherapy neoadjuvant treatment, and no disease progression; 5. Within 6 weeks before neoadjuvant treatment, completed baseline chest CT + PET-CT examination. For cN1-2 or central-type tumors, invasive mediastinal staging such as EBUS/EUS is required; 6. Within 2 - 6 weeks after neoadjuvant treatment, completed re-staging examination to confirm no distant metastasis; 7. ECOG performance status score 0 - 2 points; 8. Pulmonary function: FEV1% predicted value >= 60%, DLCO% predicted value >= 50%; 9. Normal function of major organs (blood routine, liver and kidney function, coagulation function, etc. meet the surgical requirements); 10. Voluntarily signed informed consent form and can cooperate to complete 3-year follow-up.
Exclusion criteria
Exclusion criteria: 1. After neoadjuvant treatment, the re-staging indicated distant metastasis (M1) or local progression that could not be surgically removed; 2. Had a history of thoracic surgery or thoracic radiotherapy; 3. Had uncontrollable comorbidities (such as severe coronary heart disease, uncontrolled diabetes, active autoimmune diseases, etc.); 4. Pregnant or lactating women; 5. Allergic to surgical anesthetic drugs or immunotherapy drugs; 6. Expected survival period < 6 months; 7. Participating in other interventional clinical trials; 8. Not suitable for minimally invasive surgery (requiring direct thoracotomy) as assessed by MDT.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3 year DFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3 year overall survival (OS);Incidence of surgical complications;R0 resection rate; | — |
Countries
China
Contacts
Public ContactGuangsuo Wang
Shenzhen People's Hospital
Outcome results
None listed