Pulsed Field Ablation for the Treatment of Malignant Lung Tumors

Prior treatment

• Imaging performed within 1 month before the procedure showing lymph node metastasis or extrapulmonary metastasis, except for extrapulmonary metastases that have been controlled by local treatment.
• A history of arrhythmia within the previous 2 years, including atrial tachyarrhythmia or any ventricular tachyarrhythmia; a history of second-degree Mobitz type II or third-degree atrioventricular block; or sinus bradycardia with a heart rate below 45 beats per minute.
• The target lesion has received radiotherapy within the previous 6 months.
• Current participation in another clinical study involving an investigational product.

Other illness

• Severe bleeding tendency or an uncorrectable coagulation disorder, including a prothrombin time greater than 18 seconds or prothrombin activity less than 40%.
• A condition considered to confer a high risk for the ablation procedure, including severe comorbidities, active infection, severe pulmonary arterial hypertension, severe heart disease, severe hypertension, or severe respiratory failure.
• The shortest distance between the target lesion and the trachea, main bronchus, esophagus, branches of the aortic arch, main pulmonary artery, right or left pulmonary artery trunk, or heart is less than 1 cm; or the distance between the pleural margin of the tumor and the pleura is less than 1 cm.
• A cardiac pacemaker, implantable cardioverter-defibrillator, or another electronic device or metal component is present within or near the planned ablation area.
• Any other condition that, in the investigator's judgment, makes the individual unsuitable for participation in this study.

Lab values

• Platelet count less than 70 x 10\^9/L, or anticoagulant and/or antiplatelet medication that has not been discontinued for at least 1 week before ablation, except for prophylactic preoperative use of low-molecular-weight heparin.

Other

• Extensive pulmonary metastases with an estimated survival of less than 3 months.
• Eastern Cooperative Oncology Group (ECOG) performance status greater than 2.
• Contraindication to bronchoscopy.
• Contraindication to general anesthesia.
• Pregnancy or breastfeeding, or a female or male participant planning pregnancy or conception during the study.

• Age 18 years or older.
• Pathologically confirmed primary peripheral non-small cell lung cancer with a clinical stage of T1N0M0, stage IA, including newly developed tumors after surgery and multiple primary lung cancers; or pulmonary metastatic tumors for which the primary lesion has been completely resected and the maximum tumor diameter is 3 cm or less.
• No more than three lung tumors.
• The participant refuses surgery or is considered unsuitable for surgery.
• The participant refuses or is considered unsuitable for radiotherapy, has not responded to previous radiotherapy, or has experienced disease progression after radiotherapy.
• In the investigator's judgment, the target lesion can be reached through the bronchial route and pulsed field ablation is technically feasible.
• The participant voluntarily agrees to participate, provides written informed consent, and is able and willing to comply with all study procedures.