Safety and Efficacy Study of Pulsed Electric Field (PEF) Therapy in Patients With Advanced or Unresectable Esophageal Squamous Cell Carcinoma

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Esophageal Cancer
• Intervention / Treatment: Device: PEF treatment

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Xu; Phone Number: +86 021 52230973; Email: info@energenxmedical.com

Study Locations

• China
  • Shanghai, China
    • Shanghai Chest Hospital
    • Contact: Zhigang Li, M.D., Ph.D.; Phone Number: 021-22200000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged 20 years or older when signing the informed consent form.
2. Able to provide written informed consent, and understand and follow the study requirements and assessment schedule.
3. Screening period tumor patients ECOG performance status score of 0 or 1.

4. 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
   • Hemoglobin ≥9 g/dL or ≥5.6 mmol/L
   • Serum total bilirubin ≤ 1.5 x ULN.
5. Females of childbearing potential must have a negative serum pregnancy test at screening and be willing to undergo additional pregnancy testing during the study.

Exclusion Criteria:

1. Subjects with active respiratory tract infection who need antibiotic or antiviral treatment;
2. 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.
3. 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.
4. Evidence of complete esophageal obstruction that is not suitable for treatment, and gastroscopy cannot be performed.
5. Patients with a history of esophageal stent implantation for esophageal obstruction;
6. Patients with a history of gastrointestinal bleeding in the past 4 weeks, or gastroscopy indicates a high risk of tumor ulcer bleeding.
7. Patients with obstruction caused by anastomotic stenosis without esophageal primary lesions after previous esophageal cancer surgery.
8. Patients with active leptomeningeal disease or brain metastasis.
9. Any active malignant tumor within 5 years before screening.
10. 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.
11. Patients with positive HIV test.
12. Subjects are currently participating in other research clinical trials;
13. Subjects who are considered by the investigator to have other high-risk conditions and are not suitable for gastroscopy and surgery;
14. 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEF treatment; One group prospective clinical	Device: PEF treatment; PEF energy delivery via endoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of PEF treatment	evaluate the rate of AEs/SAEs associated with instrument-related/or surgical procedures within 30 days of PEF treatment	1 month

Collaborators and Investigators

• Sponsor: Energenx Medical LTD.

Study record dates

Study Major Dates

• Study Start (Estimated): December 25, 2024
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: December 9, 2024
• First Submitted That Met QC Criteria: December 25, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 25, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Esophageal Diseases; Carcinoma; Neoplasms, Squamous Cell; Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma; Carcinoma, Squamous Cell
• Other Study ID Numbers: EC-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No