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.
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.
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.
Single group
PEF treatment
DevicePEF energy delivery via endoscope
Safety of PEF treatment
evaluate the rate of AEs/SAEs associated with instrument-related/or surgical procedures within 30 days of PEF treatment
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This trial is not recruiting at the moment. You can still explore other options:
