Non-small cell lung cancer
Conditions
Interventions
Sub-lobectomy group:None
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-90 years, gender not limited; 2. Clinically assessed as stage IA with lesion = 2 cm; 3. Underwent robotic-assisted, thoracoscopic-assisted, or traditional open thoracic wedge resection, segmentectomy, or lobectomy, pathologically confirmed as NSCLC; 4. For sub-lobar resection patients, pathology confirms resection margin = maximum tumor diameter; for lobectomy patients, pathology confirms negative resection margins; 5. ECOG score 0-1; 6. Good organ function; 7. Willing and able to comply with study visits, treatment plans, laboratory tests, and other study procedures.
Exclusion criteria
Exclusion criteria: 1. Pathology includes malignant tumors or benign lesions of other types or undetermined types; 2. Patients with clinical or pathological non-stage IA (tumor lesion =2cm); 3. Uncertain whether STAS (Spread Through Air Spaces) has occurred; 4. Sub-lobar resection patients whose resection margin does not reach the maximum tumor diameter or lobectomy patients with positive resection margins; 5. Patients who have received any preoperative induction therapy; 6. Known history of active tuberculosis; 7. Known active infection requiring systemic treatment; 8. Patients with any known or suspected autoimmune disease or immune deficiency, except: patients with a history of hypothyroidism, if no hormone therapy is needed or if receiving physiological dose hormone replacement therapy; patients with stable type I diabetes with controlled blood glucose levels; 9. Uncontrolled active hepatitis B (defined as a positive hepatitis B surface antigen [HBsAg] test result at the screening period with HBV-DNA levels above the upper limit of normal for the study center’s laboratory); 10. (Patients with HBV-DNA levels < 500 IU/mL who have received at least 14 days of standard local antiviral therapy and are willing to continue antiviral therapy during the study period can be enrolled); active hepatitis C (defined as a positive hepatitis C surface antibody [HCsAb] test result at the screening period, HCV-RNA positive); 11. Known human immunodeficiency virus (HIV) infection (known HIV antibody positive); 12. Vaccination with a live vaccine within 30 days before surgery. This includes, but is not limited to: mumps, rubella, measles, varicella/zoster (chickenpox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine (inactivated virus vaccines are permitted); 13. Known severe or uncontrolled underlying diseases; including but not limited to hemodynamically unstable cardiovascular events within the past 6 months, symptomatic cerebrovascular events, cirrhosis with Child-Pugh grade above A; 14. According to the investigator’s judgment, patients with any disease, treatment, or laboratory abnormality that may confuse the study results or are not in the best interest of the patient to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| local-recurrence incidence; | — |
Countries
China
Contacts
Public ContactLUO QINGQUAN
Shanghai Chest Hospital
Outcome results
None listed