Status:
RECRUITING
Trial of Pulsed Electric Field Therapy in Patients With Late-stage Non-small Cell Lung Cancer
Lead Sponsor:
Energenx Medical LTD.
Conditions:
NSCLC
Eligibility:
All Genders
22+ years
Phase:
NA
Brief 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 t...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Patients should be excluded if they received surgery within 30 days.
- Patients should be excluded if they received any form of local treatment within 30 days.
- Accompanied by uncontrolled metastasis of the central nervous system.
- Have a history of severe adverse reactions to ICI.
- With uncontrolled immune system diseases or being treated with immunosuppressants.
- Severe abnormality of liver and kidney function, which was evaluated by the researchers as unsuitable for admission.
- Patients with abnormal blood coagulation and antiplatelet therapy due to cardiovascular and cerebrovascular diseases should be discontinued one week before PEF treatment according to the evaluation of clinicians.
- Accompanied by infectious diseases that cannot be effectively controlled.
- Suffered from other severe lung diseases (including interstitial pneumonia, pulmonary fibrosis, pulmonary fibrosis with emphysema, atelectasis, etc.)
- Patients who had severe cardiac dysfunction and had a history of arrhythmias in the past 2 years, including rapid atrial arrhythmias, any rapid ventricular arrhythmias, a history of degree II or III atrioventricular block, and sinus bradycardia with a heart rate of less than 45 beats per minute.
- Patients who are participating in other clinical trials.
- With a cardiac pacemaker or metal implant in the chest.
- Women who are pregnant or lactating, or who plan to become pregnant during the study.
- The researchers determined that there were other conditions in which patients were not suitable for enrollment.
- Patients who have a history of receiving non-first-line anti PD-1 immunotherapy.
Key Trial Info
Start Date :
July 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05987345
Start Date
July 6 2023
End Date
July 31 2024
Last Update
July 22 2024
Active Locations (1)
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1
The first Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510000