Serplulimab Combined With Cryoablation for Early-Stage Non-Small Cell Lung Cancer

Exclusion Criteria

• •Known history of severe hypersensitivity to any monoclonal antibody (Grade \>3, per NCI-CTCAE v5.0).
• •Prior treatment with any immune checkpoint inhibitors, such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies.
• •Known contraindications to cryoablation. Active infection requiring systemic antimicrobial therapy within 14 days prior to the first dose.
• •History of myocardial infarction within 6 months before first dose, uncontrolled arrhythmias (including QTc ≥450 ms for males or ≥470 ms for females, calculated by Fridericia formula), NYHA Class III or IV heart failure, left ventricular ejection fraction \<50%, or clinically significant pleural, pericardial, or peritoneal effusion requiring intervention.
• •Uncontrolled or symptomatic hypercalcemia (ionized calcium \>1.5 mmol/L, or total serum calcium \>12 mg/dL, or corrected calcium \>ULN).
• •History or presence of interstitial lung disease, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or other significant pulmonary conditions that may interfere with evaluation or management of potential treatment-related lung toxicity, as judged by the investigator.
• •Positive for HBsAg and detectable HBV DNA (active hepatitis B); or positive for HCV antibody and detectable HCV RNA (active hepatitis C); or positive syphilis serology (except non-active infections with specific antibody positive and non-specific antibody negative); or known HIV infection.
• •Active or suspected autoimmune disease. Patients with stable autoimmune disease not requiring systemic immunosuppressive treatment are allowed.
• •Active malignancy within 5 years, except for curatively treated localized tumors such as basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, prostate, or breast with ≥5 years disease-free interval.
• •Receipt of live or attenuated vaccines within 28 days before the first dose or planned during the study. Inactivated seasonal influenza vaccines are allowed.
• •Receipt of radical radiotherapy within 3 months before the first dose. Presence of spinal cord compression not controlled by surgery and/or radiotherapy.
• •History of deep vein thrombosis (DVT), ongoing anticoagulant or antiplatelet therapy, or history of severe bleeding or DVT associated with anti-angiogenic therapy.
• •Poorly controlled hypertension, defined as blood pressure ≥160/100 mmHg despite optimal medical therapy.
• •Underwent major surgery within 28 days prior to the first dose (major surgery is defined as a procedure requiring at least 3 weeks of recovery before study treatment).
• •Participation in another interventional clinical trial within 3 months or 5 half-lives (whichever is longer) before screening.
• •Planned or prior organ or bone marrow transplantation. Known history of psychiatric or substance abuse disorders that may interfere with study compliance or assessments.
• •Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study.