Efficacy of Argon-Helium Cryoablation Plus PD-1 Inhibitors in NSCLC

Inclusion Criteria:

* Pathologically confirmed NSCLC, stage IIIB, IIIC, or IV (AJCC 8th Edition);
* At least one measurable tumor lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1);
* Estimated survival time ≥6 months;
* Receiving argon-helium cryoablation combined with PD-1 inhibitor for the first time at our institution (for study group) or standard chemo-immunotherapy (for control group);
* Unable or unwilling to undergo surgical resection for various reasons;
* Karnofsky Performance Status (KPS) score ≥60;
* Conscious and capable of effective communication;
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.

Exclusion Criteria:

* Presence of other active malignant tumors;
* Significant uncontrolled hepatic (total bilirubin \>1.5 × upper limit of normal \[ULN\], AST/ALT \>2.5 × ULN or \>5 × ULN if liver metastases present) or renal dysfunction (creatinine clearance \<50 mL/min);
* Non-primary NSCLC (i.e., metastatic from another site);
* Known allergy or contraindication to study drugs or inability to comply with the treatment plan;
* Coexisting active tuberculosis, uncontrolled systemic infections, or other significant pulmonary diseases that would interfere with treatment or outcome assessment;
* Pregnancy or lactation;
* Severe psychiatric disorders;
* Uncorrected coagulation disorders (e.g., INR \>1.5 or platelet count \<75 × 109/L);
* Known immunodeficiency syndromes (e.g., HIV infection);
* Symptomatic hemorrhagic pleural effusion requiring urgent intervention;
* Patients who withdrew consent before randomization or were deemed non-compliant by investigators.