Clinical Trial to Evaluate the Efficacy and Safety of Pulsed Electric Field Ablation Devices in the Treatment of Lung Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PEF Treatment.
- Who it may be relevant to
- Registry conditions: NSCLC. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Device PEF Treatment
PEF Energy ablation of lung tumors
Primary outcome measures
- 6-month complete ablation rate [Time frame: 6 months]
Secondary outcome measures (5)
- Technical success rate [Time frame: immediately after the PEF ablation treatment]
- 6-month pulmonary progression-free survival rate [Time frame: 6 months after the first PEF ablation treatment]
- 12-month complete ablation rate [Time frame: 12 months after the first PEF ablation treatment]
- 12-month pulmonary progression-free survival rate [Time frame: 12 months after the first PEF ablation treatment]
- 12-month overall survival rate [Time frame: 12 months after the first PEF ablation treatment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, — Shanghai
Identifiers
NCT: NCT06739031 · LC-101