Clinical Trial to Evaluate the Efficacy and Safety of Pulsed Electric Field Ablation Devices in the Treatment of Lung Tumors

Официальное название

A Multi-center, Single-group Clinical Trial to Evaluate the Efficacy and Safety of Pulsed Electric Field (PEF) Ablation Devices in the Treatment of Lung Tumors

Обзор

The goal of this clinical trial is to verify the efficacy and safety of pulsed electric field (PEF) treatment of early-stage unreseectable non-small cell lung cancer(NSCLC) patients. The main questions it aims to answer are: * Safety of PEF treatment of early-stage unreseectable NSCLC patients. * Locoregional control of ablated lesions. * Survival and quality of life assessment of early-stage unreseectable NSCLC patients.

Вмешательства

• Устройство PEF Treatment
  PEF Energy ablation of lung tumors

Первичные конечные точки

• 6-month complete ablation rate [Срок оценки: 6 months]

Вторичные конечные точки (5)

• Technical success rate [Срок оценки: immediately after the PEF ablation treatment]
• 6-month pulmonary progression-free survival rate [Срок оценки: 6 months after the first PEF ablation treatment]
• 12-month complete ablation rate [Срок оценки: 12 months after the first PEF ablation treatment]
• 12-month pulmonary progression-free survival rate [Срок оценки: 12 months after the first PEF ablation treatment]
• 12-month overall survival rate [Срок оценки: 12 months after the first PEF ablation treatment]

Критерии участия

Inclusion criteria (all requirements must be met at the same time):

1\. Age ≥ 18 years old; 2. Pathological diagnosis of non-small cell lung cancer, with the maximum diameter of the tumor ≤ 3 cm and the number ≤ 3; 3. ECOG score ≤ 2 points; 5. According to the evaluation of the researcher, it is technically feasible to perform ablation treatment on the lesion; 6. The subject agrees to receive ablation treatment and signs the informed consent form.

Exclusion criteria (if any of the above conditions are met, the patient will be excluded):

• The subject cannot tolerate or refuses general anesthesia;
• Has a history of severe allergic reactions;
• Has contraindications to bronchoscopy or refuses bronchoscopy;

5\. Has active implants in the chest cavity or metal implants in the lung to be treated; 6. Uncorrectable coagulation abnormalities (INR>1.5 or APTT>1.5 ULN), with bleeding tendency; anticoagulant therapy and/or antiplatelet drugs are discontinued before ablation for no longer than the prescribed safety period; platelets <50×10\^9/L; 7. Severe liver and kidney dysfunction, assessed by the researchers as unsuitable for inclusion; 8. Accompanied by infectious diseases that cannot be effectively controlled; 9. Subjects with other severe lung diseases (including severe interstitial pneumonia, pulmonary fibrosis, pulmonary fibrosis combined with emphysema, atelectasis, etc.), assessed by the researchers as unsuitable for inclusion 10. Acute cardiovascular and cerebrovascular accidents such as acute cerebral infarction, acute coronary syndrome, etc. within 3 months; 11. Subjects with severe cardiac dysfunction; history of severe arrhythmias in the past 2 years, including rapid atrial arrhythmias, any rapid ventricular arrhythmias; history of II degree type II or III degree atrioventricular block; and sinus bradycardia with a heart rate of less than 45 beats per minute, etc.; 12. Subjects have participated in or are participating in other clinical trials within three months; 13. Pregnant, lactating women, or women who plan to become pregnant during the study; 14. Subjects determined by the researchers to have other conditions that are unsuitable for inclusion.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, — Шанхай

Идентификаторы

NCT: NCT06739031 · LC-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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