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.
None
The subject cannot tolerate or refuses general anesthesia;
Has a history of severe allergic reactions;
Has contraindications to bronchoscopy or refuses bronchoscopy;
Single group
PEF Treatment
DevicePEF Energy ablation of lung tumors
6-month complete ablation rate
Technical success rate
6-month pulmonary progression-free survival rate
12-month complete ablation rate
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
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
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