Non-Small-Cell Lung Cancer
Conditions
Interventions
Intervention group:(1) Multimodal ablation therapy.
(2) Neoadjuvant therapy: Neoadjuvant tislelizumab (200 mg, IV, Q3W) combined with chemotherapy will be administered within 2 weeks after ablation.
for patients with non-squamous NSCLC, cisplatin or carboplatin combined with pemetrexed will be used, for a total of 3–4 cycles of treatment.
(3) Radical surgical treatment: Surgical resection will be
Sponsors
Langfang Campus of Chinese Academy of Medical Sciences Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years, either gender; 2. Pathologically confirmed stage II-IIIB (N2) squamous or non-squamous non-small cell lung cancer (NSCLC) according to the 9th edition of the AJCC/UICC NSCLC staging system; 3. Presence of lesions suitable for ablation therapy confirmed by imaging evaluation; 4. Evaluated as resectable with R0 resection before enrollment, and consent to undergo radical surgical resection; 5. ECOG performance status score of 0-1; 6. Eligible for platinum-based doublet chemotherapy; 7. Adequate cardiopulmonary function to meet the requirements of curative surgical resection; 8. Sufficient organ function confirmed by laboratory tests within 28 days before enrollment: (1). Blood routine: WBC >= 3.0×10^9/L; ANC >= 1.5×10^9/L; PLT >= 100×10^9/L; HGB >= 90 g/L. (2). Liver function: AST = 60 mL/min. (5).For patients receiving carboplatin: creatinine clearance >= 45 mL/min. (6). Coagulation function: INR <= 1.5×ULN (<=3×ULN for patients on anticoagulants; anticoagulants must be discontinued for one week before ablation); APTT <= 1.5×ULN; 9. Fully understand the study and voluntarily sign the informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1. Tumor is adjacent to the hilum, invades major blood vessels, or has contraindications for surgery; 2. History of interstitial lung disease, non-infectious pneumonia, or uncontrolled pulmonary diseases including pulmonary fibrosis and acute lung disease; 3. Previous allogeneic stem cell transplantation or organ transplantation; 4. Previous radiotherapy or chemotherapy; 5. Previous local treatment (e.g., radioactive seed implantation, ablation) for the target ablation lesion; 6. Previous treatment with immune checkpoint inhibitors, including but not limited to anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies; 7. Complicated with severe cardiac, pulmonary, hepatic, renal insufficiency, or coagulation disorders; 8. Clinically significant cardio-cerebrovascular diseases, including but not limited to acute myocardial infarction within 6 months before enrollment, heart failure of NYHA class III or IV, ventricular arrhythmia = grade 2, any history of cerebrovascular accident; 9. Underwent any major surgical procedure requiring general anesthesia within 28 days before enrollment; 10. Previous severe immune system diseases or active infection; 11. Pregnant or lactating female; 12. Complicated with other malignancies (un cured within 5 years); 13. Confirmed positive EGFR or ALK driver genes by genetic testing; 14. Any condition requiring systemic therapy with corticosteroids (>10 mg prednisone per day or equivalent) or other immunosuppressive drugs before enrollment; 15. Severe chronic or active infection requiring systemic antibacterial, antifungal, or antiviral therapy, including tuberculosis; 16. Known history of HIV infection; 17. Untreated chronic hepatitis B patients, chronic hepatitis B virus (HBV) carriers with HBV DNA = 500 IU/mL, or active hepatitis C virus (HCV) patients; (Note: Inactive hepatitis B surface antigen carriers, treated and stable hepatitis B patients (HBV DNA < 500 IU/mL), and cured hepatitis C patients are eligible.); 18. Received live vaccine within 28 days before enrollment; 19. Simultaneously participating in another therapeutic clinical study; 20. Other conditions considered unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathological Response Rate;Event-Free Survival;Overall Survival;Safety; | — |
Countries
China
Contacts
Public ContactTan Fengwei
Langfang Campus of Chinese Academy of Medical Sciences Cancer Hospital
Outcome results
None listed