NCT06756841尚未招募不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Safety of PEF treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
- •Females of childbearing potential must have a negative serum pregnancy test at screening and be willing to undergo additional pregnancy testing during the study.
排除标准
- •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.
- •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)
结局指标
主要结局
Safety of PEF treatment
时间窗: 1 month
evaluate the rate of AEs/SAEs associated with instrument-related/or surgical procedures within 30 days of PEF treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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