Actively Recruiting
Trial of Pulsed Electric Field Therapy in Patients With Late-stage Non-small Cell Lung Cancer
Led by Energenx Medical LTD. · Updated on 2024-07-22
10
Participants Needed
1
Research Sites
55 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Trial of Pulsed Electric Field Therapy in Patients With Late-stage Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 22 years old with pathologically confirmed non-small cell lung cancer stage III-IV.
- Patients who received first-line anti PD-1 immunotherapy and had disease progression.
- Lesions to be ablated must be 3 cm or less in longest diameter, or up to 5 cm if multiple energy deliveries in one session are possible.
- More than one measurable lesion according to RECIST 1.1 except PEF targeted lesions.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Life expectancy of at least 3 months.
- Fully understand the treatment plan and voluntarily sign the informed consent form.
You will not qualify if you...
- Surgery within 30 days before enrollment.
- Any form of local treatment within 30 days before enrollment.
- Uncontrolled metastasis of the central nervous system.
- History of severe adverse reactions to immune checkpoint inhibitors.
- Uncontrolled immune system diseases or current treatment with immunosuppressants.
- Severe liver or kidney function abnormalities deemed unsuitable by researchers.
- Abnormal blood coagulation requiring antiplatelet therapy that cannot be stopped one week before PEF treatment.
- Infectious diseases that cannot be effectively controlled.
- Severe lung diseases such as interstitial pneumonia, pulmonary fibrosis, pulmonary fibrosis with emphysema, or atelectasis.
- Severe cardiac dysfunction or history of serious arrhythmias within the past 2 years.
- Participation in other clinical trials.
- Presence of a cardiac pacemaker or metal implant in the chest.
- Women who are pregnant, lactating, or planning pregnancy during the study.
- Other conditions deemed unsuitable for enrollment by researchers.
- History of receiving anti PD-1 immunotherapy other than first-line treatment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The first Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
S
Sara Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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