Patients with non-small cell carcinoma confirmed by histology or cytology, IB (no pleural invasion, lesion > 4 cm) - stage IIIB (International Association for the study of lung cancer and the 9th edition of the American Joint Committee on classification of Cancer TNM lung cancer staging) NSCLC with definite staging such as chest enhanced CT, liver and adrenal enhanced CT, cranial magnetic resonanc
Conditions
Interventions
KangBo knife combined with teriprizumab and chemotherapy treatment group:Neoadjuvant therapy of combined thermal and cold ablation combined with teriprizumab and chemotherapy
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) patients with stage IB (no pleural invasion, lesion >4 cm) to IIIB (according to the 9th edition of the TNM lung cancer staging system by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer), who have not received prior antitumor therapy and have been clearly staged by contrast-enhanced chest CT, contrast-enhanced liver and adrenal CT, brain MRI, PET-CT/whole-body bone scintigraphy, etc.; 2. Patients aged 18 to 75 years, able to provide informed consent and sign the informed consent form, and able to comply with the study protocol and follow-up procedures; 3. Subjects with potentially resectable NSCLC as assessed by multidisciplinary team (MDT) evaluation, and with lung tumor lesions amenable to biopsy and combined cryo-thermal ablation; 4. Life expectancy >6 months; 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 6. Willing to provide tissue from the tumor lesion; 7. Adequate pulmonary function, defined as forced expiratory volume in the first second (FEV1) >=1.2 L/s or >=50% of predicted value, and postoperative predicted FEV1 >=30%; 8. No history of other primary lung malignancies and no prior antitumor therapy for lung cancer; 9. At least 4 weeks since the last hormone therapy, and all adverse events from prior treatments have recovered to =9.0 g/dL (may be maintained by transfusion or above this level); (2) Red blood cell count >=2.0×10^9/L, absolute neutrophil count (ANC) >=1.0×10^9/L; (3) Platelet count >=90×10^9/L; (4) Total bilirubin =60 mL/min; (7) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, participants with total T3 (or FT3) and FT4 within the normal range may also be enrolled; (8) Cardiac enzyme levels within the normal range (isolated laboratory abnormalities deemed clinically insignificant by the investigator's comprehensive judgment are also allowed for enrollment); (9) For patients not receiving anticoagulant therapy, international normalized ratio (INR) <=1.5 and activated partial thromboplastin time (APTT) <=1.5 times ULN. Patients receiving full-dose or parenteral anticoagulant therapy may be enrolled if the anticoagulant dose has been stable for at least 2 weeks before study entry and coagulation parameters are within the local therapeutic range; all other screening laboratory values must meet the relevant criteria; 11. Women of childbearing potential must have a negative urine and serum HCG test within 7 days before the start of treatment; male and female patients of childbearing potential must agree to use reliable methods of contraception during the study period and until 180 days after the last dose. Reliable contraceptive methods will be determined by the principal investigator or designee.
Exclusion criteria
Exclusion criteria: 1. Pathologically confirmed small cell lung cancer (SCLC), including mixed SCLC and NSCLC; 2. Exclusion of patients with positive driver gene alterations: a) Positive by histological testing: Confirmation of any of the following driver gene alterations in histopathological samples (surgical, biopsy or cytological specimens): EGFR (L858R, exon 19 deletion, S768I, L861Q, G719X, exon 20 insertion); ALK fusion; ROS1 fusion; MET exon 14 skipping mutation and amplification; KRAS G12C; BRAF V600E; NTRK 1/2/3; RET fusion; HER2 (ERBB 2); b) Positive by liquid biopsy: Confirmation of any of the above driver gene mutations by circulating tumor DNA (ctDNA) testing; 3. Conditions unsuitable for puncture and ablation, including: a) Active hemoptysis within 2 weeks (at least 1/2 teaspoon of fresh blood expectorated at one time); b) Patients with bleeding tendency (e.g., active peptic ulcer) or those receiving anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; provided that the prothrombin time international normalized ratio (INR) is = New York Heart Association class II), myocardial infarction (within 6 months before enrollment), severe cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease); 5. Patients with uncontrolled neurological disorders (grade 2 or higher) or psychiatric disorders; patients with active, known or suspected autoimmune diseases; subjects with the following conditions may be enrolled: vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis; 6. Prior treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody acting on T-cell co-stimulatory or checkpoint pathways) with no response or progression; 7. Active pulmonary tuberculosis suggested by chest X-ray, sputum examination or nucleic acid-PCR; history of active pulmonary tuberculosis treatment within 1 year; for patients with a history of active pulmonary tuberculosis >1 year ago, the lesion must have been controlled for >1 year and the efficacy of anti-tuberculosis treatment must be confirmed; 8. Known positive history of human immunodeficiency virus (HIV) test or known acquired immunodeficiency syndrome (AIDS); 9. Comorbidities requiring treatment with immunosuppressive drugs, or comorbidities requiring systemic or local corticosteroids at immunosuppressive doses; 10. Pregnant or breastfeeding women, and male or female patients who refuse to adopt appropriate contraceptive measures; 11. Previous or anticipated organ or bone marrow transplantation during the study period; 12. Combined with interstitial pneumonia, pneumoconiosis, drug-induced pneumonia, or severely impaired pulmonary function; 13. Diagnosis of malignancies other than NSCLC within 2 years (excluding curatively treated basal cell carcinoma of the skin, sq
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response (pCR) Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response Rate;R0 resection rate;Overall survival;Major Pathological Response (mPR) Rate;Event free survival;Overall Response Rate;Treat related adverse events;Changes in the quality of life score; | — |
Countries
China
Contacts
Public ContactLiao Hu
West China Hospital of Sichuan University
Outcome results
None listed