Esophageal CancerNCT06756841
Safety and Efficacy Study of Pulsed Electric Field (PEF) Therapy in Patients With Advanced or Unresectable Esophageal Squamous Cell Carcinoma
A study testing PEF treatment in people with Esophageal Cancer, run by Energenx Medical LTD. at 1 site in China.
Trial summary
The goal of this clinical trial is to verify the safety and clinical benefit of pulsed electric field (PEF) treatment of advanced or unresectable esophageal squamous cell carcinoma patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- PEF treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2024to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 20 years or older when signing the informed consent form.
- Able to provide written informed consent, and understand and follow the study requirements and assessment schedule.
- Screening period tumor patients ECOG performance status score of 0 or 1.
- Laboratory test data within 7 days before the planned PEF treatment date during the screening period must meet the following standards.
- Neutrophil count (ANC) ≥1500 cells/mm3
- Platelet count ≥100,000 cells/mm3
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- Hemoglobin ≥9 g/dL or ≥5.6 mmol/L
- Serum total bilirubin ≤ 1.5 x ULN.
- Females of childbearing potential must have a negative serum pregnancy test at screening and be willing to undergo additional pregnancy testing during the study.
Who cannot join
- Subjects with active respiratory tract infection who need antibiotic or antiviral treatment;
- Patients with locally advanced ESCC whose tumors can be surgically removed by the investigator or can be potentially cured by radical chemoradiotherapy according to the judgment of local investigators.
- Patients with esophageal lesions that severely invade adjacent organs (esophagus/bronchus or esophagus/aorta) and are assessed as high-risk esophageal leakage/fistula by the investigator.
- Evidence of complete esophageal obstruction that is not suitable for treatment, and gastroscopy cannot be performed.
- Patients with a history of esophageal stent implantation for esophageal obstruction;
- Patients with a history of gastrointestinal bleeding in the past 4 weeks, or gastroscopy indicates a high risk of tumor ulcer bleeding.
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- Patients with obstruction caused by anastomotic stenosis without esophageal primary lesions after previous esophageal cancer surgery.
- Patients with active leptomeningeal disease or brain metastasis.
- Any active malignant tumor within 5 years before screening.
- Subjects have undergone metal implantation surgery such as esophageal stents and airway stents. Or the patient has an implantable cardioverter-defibrillator, pacemaker or other implantable electronic device.
- Patients with positive HIV test.
- Subjects are currently participating in other research clinical trials;
- Subjects who are considered by the investigator to have other high-risk conditions and are not suitable for gastroscopy and surgery;
- Subjects who have adverse events that have not yet returned to baseline or stable levels due to previous anti-tumor treatment, except for adverse events that do not pose safety risks (such as hair loss and abnormal values of specific laboratory tests)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Chest Hospital
Shanghai
Zhigang Li, M.D., Ph.D., 021-22200000
About this study
Official title: A Single-arm Clinical Trial to Explore the Safety and Efficacy of Pulsed Electric Field (PEF) Therapy in Patients With Advanced or Unresectable Esophageal Squamous Cell Carcinoma
The goal of this clinical trial is to verify the safety and clinical benefit of pulsed electric field (PEF) treatment of advanced or unresectable esophageal squamous cell carcinoma patients.
The main questions it aims to answer are:
- Safety and feasibility of PEF treatment of patients with advanced or unresectable esophageal squamous cell carcinoma.
- Locoregional control of ablated lesions and quality of life assessment.
- Local and peripheral immunoregulation effect.
- Conditions
- Esophageal Cancer
- Being tested
- PEF treatment
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEF treatmentDevice
PEF energy delivery via endoscope
| Study group | Role | What they receive |
|---|---|---|
| PEF treatment | Experimental | One group prospective clinical Receives: Device: PEF treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of PEF treatment
evaluate the rate of AEs/SAEs associated with instrument-related/or surgical procedures within 30 days of PEF treatment
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start25 Dec 2024 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Energenx Medical LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756841
- Sponsor's protocol ID
- EC-001
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Clinical Trial to Explore the Safety and Efficacy of Pulsed Electric Field (PEF) Therapy in Patients With Advanced or Unresectable Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06756841
- Acronym / sponsor ID
- EC-001
- Conditions
- Esophageal Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Energenx Medical LTD.Industry (pharma, biotech, devices)
- Study start
- 25 Dec 2024 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to verify the safety and clinical benefit of pulsed electric field (PEF) treatment of advanced or unresectable esophageal squamous cell carcinoma patients.
The main questions it aims to answer are:
- Safety and feasibility of PEF treatment of patients with advanced or unresectable esophageal squamous cell carcinoma.
- Locoregional control of ablated lesions and quality of life assessment.
- Local and peripheral immunoregulation effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEF treatment | Experimental | Device: PEF treatmentOne group prospective clinical |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 20 years or older when signing the informed consent form.
- Able to provide written informed consent, and understand and follow the study requirements and assessment schedule.
- Screening period tumor patients ECOG performance status score of 0 or 1.
- Laboratory test data within 7 days before the planned PEF treatment date during the screening period must meet the following standards.
- Females of childbearing potential must have a negative serum pregnancy test at screening and be willing to undergo additional pregnancy testing during the study.
Key exclusion criteria (14 listed)
- Subjects with active respiratory tract infection who need antibiotic or antiviral treatment;
- Patients with locally advanced ESCC whose tumors can be surgically removed by the investigator or can be potentially cured by radical chemoradiotherapy according to the judgment of local investigators.
- Patients with esophageal lesions that severely invade adjacent organs (esophagus/bronchus or esophagus/aorta) and are assessed as high-risk esophageal leakage/fistula by the investigator.
- Evidence of complete esophageal obstruction that is not suitable for treatment, and gastroscopy cannot be performed.
- Patients with a history of esophageal stent implantation for esophageal obstruction;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEF treatmentPEF energy delivery via endoscope | Device | PEF treatment |
Primary outcome
Safety of PEF treatment
Time frame: 1 month
evaluate the rate of AEs/SAEs associated with instrument-related/or surgical procedures within 30 days of PEF treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEF treatment in people with Esophageal Cancer, run by Energenx Medical LTD. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Xu (+86 021 52230973, info@energenxmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of PEF treatment (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.