Trial of Pulsed Electric Field Therapy in Patients With Late-stage Non-small Cell Lung Cancer
NCT05987345 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2024-07-22
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.
Conditions
Interventions
- DEVICE
-
PEF
PEF device treated in the trial.
- DRUG
-
Anti-PD-1 monoclonal antibody
Anti-PD-1 monoclonal antibody administered on Day 7 then routinely.
Sponsors & Collaborators
-
Energenx Medical LTD.
lead INDUSTRY
Principal Investigators
-
Shiyue Li, MD · The first Affiliated Hospital of Guanzhou Medical University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 22 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-07-06
- Primary Completion
- 2024-07-31
- Completion
- 2024-07-31
Countries
- China
Study Locations
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