Safety and Clinical Efficacy Evaluation of Pulsed Electric Field Therapy in Patients With Late-stage Non-small Cell Lung Cancer

Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: f
View:

• Patients over 22 years old with pathologically confirmed non-small cell lung cancer stage III-IV.

• Patients received first-line anti PD-1 immunotherapy and had disease progression.

• Lesions to be ablated must be ≤ 3cm in longest diameter(LD).

• \* The leison to be ablated can be ≤ 5cm in LD, if evaluated as possible with multiple energy delivery in a single session.

• More than one measurable lesion according to RECIST 1.1 except PEF targeted lesions.

• Eastern Cooperative Oncology Group(ECOG) performance status 0-1

• Life expectancy ≥3 months

• Fully understand the treatment plan and sign the informed consent form voluntarily.

Locations
Other Locations
China
The first Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
Contact Information
Primary
Sara Xu
info@energenxmedical.com
+86 021 52230973
Time Frame
Start Date: 2023-07-06
Estimated Completion Date: 2024-07-31
Participants
Target number of participants: 10
Treatments
Experimental: PEF treatment
All of participants who signed the Informed Consent Form(ICF) and meet all of inclusion and exclusion criterial will be enrolled to experimental arm. PEF treatment on Day 1, followed by anti PD-1 on Day 7 and then routinely.
Sponsors
Leads: Energenx Medical LTD.

This content was sourced from clinicaltrials.gov