About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- PEF treatment