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

Other illness

• Presence of other active malignant tumors;
• 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;
• Severe psychiatric disorders;
• Known immunodeficiency syndromes (e.g., HIV infection);

Lab values

• 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);
• Uncorrected coagulation disorders (e.g., INR \>1.5 or platelet count \<75 × 109/L);

Other

• Non-primary NSCLC (i.e., metastatic from another site);
• Pregnancy or lactation;
• Symptomatic hemorrhagic pleural effusion requiring urgent intervention;
• Patients who withdrew consent before randomization or were deemed non-compliant by investigators.

• 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.