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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEF Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEF Treatment | Device | PEF Energy ablation of lung tumors |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6-month complete ablation rate | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success rate | immediately after the PEF ablation treatment | |
| 6-month pulmonary progression-free survival rate | 6 months after the first PEF ablation treatment | |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Intervention | All adverse events were recorded and evaluated according to CTCAE v5.0 (if applicable), and the relevance to the device itself and the treatment was evaluated. The incidence of device-related and surgical treatment-related adverse events and serious adverse events was calculated | 12 months |
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):
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara Xu | Contact | 021 | sara.xu@energenxmedical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, | Shanghai | China |
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| 12-month complete ablation rate |
| 12 months after the first PEF ablation treatment |
| 12-month pulmonary progression-free survival rate | The proportion of subjects with no pulmonary progression (the first ablation lesion maintained no progression, no hilar lymph node metastasis, no new lesions) accounted for the proportion of evaluable subjects who received ablation | 12 months after the first PEF ablation treatment |
| 12-month overall survival rate | 12 months after the first PEF ablation treatment |