Lung cancer
Conditions
Interventions
Lobar resection group:None
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 85 years, with no gender restriction; 2. Clinically staged as IA, and chest CT imaging shows lesions <= 2 cm; 3. Received robot-assisted, laparoscopy-assisted, or traditional open thoracotomy wedge resection, segmentectomy, or lobectomy, with pathology confirming NSCLC and the presence of VPI; 4. For sublobar resection patients, pathology confirms that the resection margin is at least = the maximum tumor diameter or 2 cm, and for lobectomy patients, the resection margin is negative; 5. ECOG performance status of 0-1; 6. Good organ function; 7. Voluntarily agrees to participate in the study, signs the informed consent form, and is able to comply with the study’s visit schedule, treatment plan, laboratory tests, and other research procedures.
Exclusion criteria
Exclusion criteria: 1. Pathology reveals other types of malignancies (including small cell lung cancer) or malignant tumors of undetermined type, or benign lesions; 2. Clinically or pathologically staged as non-IA (lesion diameter > 2 cm) patients; 3. Unclear whether VPI has occurred; 4. For sublobar resection patients, resection margin does not meet the tumor's maximum diameter or for lobectomy patients, resection margin is positive; 5. Received any preoperative induction therapy; 6. Known history of active tuberculosis; 7. Known active infection requiring systemic treatment; 8. Any known or suspected autoimmune diseases or immune deficiencies, except: patients with a history of hypothyroidism who do not require hormone therapy, or are receiving physiological doses of hormone replacement therapy; patients with stable type 1 diabetes with controlled blood glucose; 9. Uncontrolled active hepatitis B (defined as positive screening for hepatitis B surface antigen [HBsAg] and detectable HBV-DNA levels exceeding the upper limit of normal for the testing laboratory at the research center); 10. (Patients with HBV-DNA < 500 IU/mL who have received at least 14 days of local standard antiviral therapy and are willing to continue antiviral treatment during the study may be included); Active hepatitis C (defined as positive screening for hepatitis C surface antibody [HCV-Ab] and detectable HCV-RNA) patients; 11. Known HIV infection (HIV antibody positive); 12. Received live vaccines within 30 days prior to surgery, including but not limited to: mumps, rubella, measles, varicella/zoster (chickenpox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccines (inactivated virus vaccines are allowed); 13. Known severe or uncontrolled underlying diseases, including but not limited to: hemodynamically unstable cardiovascular events within 6 months, symptomatic cerebrovascular events, liver cirrhosis with a Child-Pugh score greater than A; 14. Any disease, treatment, or laboratory abnormality history, or current evidence deemed by the investigator to potentially confound the study results or not be in the best interest of the patient to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5-year overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| 5-year recurrence-free survival; | — |
Countries
China
Contacts
Public ContactQingquan Luo
Shanghai Chest Hospital
Outcome results
None listed