Percutaneous Pulsed Electric Field Ablation for Early-Stage NSCLC and Lung Oligometastases: A Safety and Efficacy Study

Prior treatment

• Received any form of local tumor therapy for the target lung tumor lesion(s) within 6 months.
• Currently receiving systemic anti-tumor therapy, such as chemotherapy, targeted therapy, immunotherapy etc.
  • (For pulmonary oligometastatic tumors with primary cancer controlled already, if systemic anti-tumor therapy still needs to be continued, it is acceptable. For primary NSCLC patients, according to guideline recommendations, no concurrent systemic anti-tumor therapy is indicated).
• Currently using anticoagulant therapy and/or antiplatelet drugs (such as warfarin, dabigatran, rivaroxaban, and other new oral anticoagulants) and have not been discontinued for more than 5 to 7 days prior to ablation therapy.
• Receiving high-dose immunosuppressive drugs (prednisone exceeding 10mg/day or equivalent). If discontinued for more than 4 weeks, it is acceptable.
• There is metal implants near the lesion to be ablated lesion (distance \< 2-3cm) in the lung.

Other illness

• The distance between tumor lesion edge and important structures such as heart, diaphragm and mediastinum is less than 10mm.
• With a history of hypersensitivity to medications to be used in general anesthesia or drugs required during the procedure/follow-up (such as contrast-enhanced CT scan).
• Uncontrolled lung or systemic infection. Or uncontrolled skin infection at the puncture site or fever \> 38.5°C.
• Subject has comorbidity of severe other lung diseases (including interstitial pneumonia, pulmonary fibrosis, severe emphysema or atelectasis) and unsuitable for enrollment with the judgement of the investigator.
• Malignant pleural effusion on the treatment side of lung.
• Severe uncontrolled hypertension, diabetes, severe abnormal liver or kidney function, or heart failure that investigator assessed as unsuitable for enrollment.
• Acute cardio-cerebrovascular events within 3 months, such as acute hemorrhagic or ischemic stroke, acute coronary syndrome, acute myocardial infarction.
• Psychiatric disease that not well controlled.
• With a history of recurrent tachyarrhythmia past 2 years. (Including rapid atrial arrhythmias, any rapid ventricular arrhythmias); or history of type II second-degree or III degree atrioventricular block or sinus bradycardia with heart rate \< 45 beats/min, or sinus tachycardia \> 120 beats/min.

Lab values

• Anemia (Hemoglobin (HGB) \< 9 g/dL), dehydration, and severe metabolic disorders that cannot be improved or well managed in the short term.
• Coagulation abnormalities (INR \>1.5 or APTT \>1.5 ULN), or platelet count below 90 x 10\^9/L.

Other

• Implanted electronic device in the body (such as pacemaker, implantable cardioverter defibrillator, or neurostimulator).
  • (it is acceptable If the implanted electronic device is allowed to be turned off during the procedure)
• Patient is currently participating in another clinical trial.
• Pregnant or breastfeeding women, or women planning to become pregnant during the study period.
• Other situations judged by investigator as unsuitable for enrollment.

• Age ≥18 years but ≤ 79 years, male or female
• Pathologically diagnosed primary NSCLC and stage IA, or oligometastatic lung tumors that primary cancer has been controlled. the maximum diameter of the lesion is ≤3cm, (Pathological diagnosis includes conventional pathological examination or ROSE rapid on-site evaluation)
• For multiple primary lung cancers, the number of lesions is ≤3 and the maximum diameter of the lesion(s) is ≤3cm. For metastatic tumors, the number of lesions in one side of lung is ≤3 (total lesions in both sides \<5), the maximum diameter of the lesion(s) is ≤3cm.
• ECOG score ≤ 2;
• Expected survival ≥ 12 months;
• Clinical assessment as unsuitable for surgical resection or refusing surgery and radiotherapy.
• Assessed by an anesthesiologist as suitable for general anesthesia;
• Agree to receive ablation therapy and sign the informed consent form.