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Trial Title:
Trial of Pulsed Electric Field Therapy in Patients With Late-stage Non-small Cell Lung Cancer
NCT ID:
NCT05987345
Condition:
NSCLC
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Antibodies
Antibodies, Monoclonal
Conditions: Keywords:
NSCLC
PEF
Immune Checkpoint Inhibitor(ICI)
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
PEF
Description:
PEF device treated in the trial.
Arm group label:
PEF treatment
Intervention type:
Drug
Intervention name:
Anti-PD-1 monoclonal antibody
Description:
Anti-PD-1 monoclonal antibody administered on Day 7 then routinely.
Arm group label:
PEF treatment
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.
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 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients over 22 years old with pathologically confirmed non-small cell lung cancer
stage III-IV.
2. Patients received first-line anti PD-1 immunotherapy and had disease progression.
3. 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.
4. More than one measurable lesion according to RECIST 1.1 except PEF targeted lesions.
5. Eastern Cooperative Oncology Group(ECOG) performance status 0-1
6. Life expectancy ≥3 months
7. Fully understand the treatment plan and sign the informed consent form voluntarily.
Exclusion Criteria:
1. Patients should be excluded if they received surgery within 30 days.
2. Patients should be excluded if they received any form of local treatment within 30
days.
3. Accompanied by uncontrolled metastasis of the central nervous system.
4. Have a history of severe adverse reactions to ICI.
5. With uncontrolled immune system diseases or being treated with immunosuppressants.
6. Severe abnormality of liver and kidney function, which was evaluated by the
researchers as unsuitable for admission.
7. 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.
8. Accompanied by infectious diseases that cannot be effectively controlled.
9. Suffered from other severe lung diseases (including interstitial pneumonia,
pulmonary fibrosis, pulmonary fibrosis with emphysema, atelectasis, etc.)
10. 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.
11. Patients who are participating in other clinical trials.
12. With a cardiac pacemaker or metal implant in the chest.
13. Women who are pregnant or lactating, or who plan to become pregnant during the
study.
14. The researchers determined that there were other conditions in which patients were
not suitable for enrollment.
15. Patients who have a history of receiving non-first-line anti PD-1 immunotherapy.
Gender:
All
Minimum age:
22 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The first Affiliated Hospital of Guangzhou Medical University
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Status:
Recruiting
Contact:
Last name:
Li Shiyue, MD
Start date:
July 6, 2023
Completion date:
July 31, 2024
Lead sponsor:
Agency:
Energenx Medical LTD.
Agency class:
Industry
Source:
Energenx Medical LTD.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05987345
