The goal of this clinical trial is to verify the safety and clinical benefit of pulsed electric field(PEF) treatment of metastatic non-small cell lung cancer(NSCLC) patients with acquired resistance to anti programmed cell death protein 1(PD-1) monoclonal antibody therapy. The main questions it aims to answer are: * Safety of PEF treatment of metastatic NSCLC patients. * Control of ablated and other targeted lesions. * Local and peripheral immunoregulation effect. PEF energy will be delivered to preselected lesions of participants, then anti PD-1 will be routinely administrated if no adverse event(AE)/serious adverse event(SAE) which need medical intervention occurs.
Eligible patients will will be enrolled to experimental arm and receive standard of care combining with PEF treatment on Day 1, followed by anti PD-1 on Day 7 and then routinely. All kinds of adverse events will be recorded and analyzed to evaluate the safety of the treatment. At the same time, the local control rate of treated lesions, PFS and OS after PEF will be analyzed to evaluate the clinical value of the treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
PEF device treated in the trial.
Anti-PD-1 monoclonal antibody administered on Day 7 then routinely.
The first Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGTechnical success rate of PEF treatment
The percentage of the number that the equipment successfully reached the target lesion and completed PEF energy delivery.
Time frame: 7 days
Incidence of PEF treatment related AE/SAEs
The incidence and severity of PEF treatment related adverse events according to CTCAE version 4.0
Time frame: 1 month
Local control of ablated lesions by CT
Compared with the baseline CT scan before treatment, the maximum diameter of the ablated lesion decreased, remained unchanged or increased by less than 20%.
Time frame: 3 months
Local control of ablated lesions by CT
Compared with the baseline CT scan before treatment, the maximum diameter of the ablated lesion decreased, remained unchanged or increased by less than 20%.
Time frame: 6 months
Progression free survival rate at 6 months
Time frame: 6 months
Overall survival rate at 6 months
Time frame: 6 months
Overall survival rate at 12 months
Time frame: 12 months
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