A Clinical Study To Evaluate Safety, Technical Feasibility, and Preliminary Efficacy of A Pulsed Electrical Field Ablation Through Percutaneous Approach For Treatment of Patient With Primary Early-Stage Non-Small Cell Lung Cancer or Lung Oligo-metastatic Tumor Who Are Unresectable or Refusal to Surgery/Radiotherapy.
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
- The clinical safety of the device and/or procedure in the operation of PEF ablation and entire study follow-up.
研究概览
简要总结
The goal of this observational study is to evaluate the performances of a percutaneous Pulsed Electrical Field (PEF) ablation to treat patients with primary early-stage lung cancer (NSCLC) or lung oligometastatic Tumors who are unresectable or refusal surgery/Radiotherapy.
The main questions the study aims to answer are:
The safety and technical feasibility of the PEF ablation. The preliminary efficacy of the PEF ablation for target lesion in lung
Patients who meet the inclusion/exclusion criteria will be given percutaneous PEF ablation to the target lesions under general anesthesia. Then follow-up to 12 months to monitor any progression by about 3 months interval.
Target Subject： Patients with early-stage primary non-small cell lung cancer(NSCLC) or pulmonary oligometastatic tumors who are not surgical resectable or unsuitable for surgery/radiotherapy
详细描述
Safety, technical feasibility including procedure operation success and tumor ablation technical success be evaluated.
The primary efficacy endpoint is the complete ablation rate of the ablated lesions at month 6.
Other efficacy endpoints are local tumor progression-Free Survival(PFS), Overall Survival (OS) and proportion of patients requiring initiation of other anti-tumor interventions through 12 months. Pulmonary function and quality of life (EORTC QLQ-C30, EORTC QLQ-LC13) will be assessed as well.
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
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years but ≤ 79 years, male or female
- •Pathologically diagnosed primary NSCLC and stage IA, or oligometastatic lung tumors that primary cancer has been controlled. the maximum diameter of the lesion is ≤3cm, (Pathological diagnosis includes conventional pathological examination or ROSE rapid on-site evaluation)
- •For multiple primary lung cancers, the number of lesions is ≤3 and the maximum diameter of the lesion(s) is ≤3cm. For metastatic tumors, the number of lesions in one side of lung is ≤3 (total lesions in both sides <5), the maximum diameter of the lesion(s) is ≤3cm.
- •ECOG score ≤ 2;
- •Expected survival ≥ 12 months;
- •Clinical assessment as unsuitable for surgical resection or refusing surgery and radiotherapy.
- •Assessed by an anesthesiologist as suitable for general anesthesia;
- •Agree to receive ablation therapy and sign the informed consent form.
排除标准
- •Received any form of local tumor therapy for the target lung tumor lesion(s) within 6 months.
- •Currently receiving systemic anti-tumor therapy, such as chemotherapy, targeted therapy, immunotherapy etc.
- •(For pulmonary oligometastatic tumors with primary cancer controlled already, if systemic anti-tumor therapy still needs to be continued, it is acceptable. For primary NSCLC patients, according to guideline recommendations, no concurrent systemic anti-tumor therapy is indicated).
- •The distance between tumor lesion edge and important structures such as heart, diaphragm and mediastinum is less than 10mm.
- •With a history of hypersensitivity to medications to be used in general anesthesia or drugs required during the procedure/follow-up (such as contrast-enhanced CT scan).
- •Anemia (Hemoglobin (HGB) < 9 g/dL), dehydration, and severe metabolic disorders that cannot be improved or well managed in the short term.
- •Coagulation abnormalities (INR >1.5 or APTT >1.5 ULN), or platelet count below 90 x 10^9/L.
- •Uncontrolled lung or systemic infection. Or uncontrolled skin infection at the puncture site or fever > 38.5°C.
- •Currently using anticoagulant therapy and/or antiplatelet drugs (such as warfarin, dabigatran, rivaroxaban, and other new oral anticoagulants) and have not been discontinued for more than 5 to 7 days prior to ablation therapy.
- •Receiving high-dose immunosuppressive drugs (prednisone exceeding 10mg/day or equivalent). If discontinued for more than 4 weeks, it is acceptable.
- •Subject has comorbidity of severe other lung diseases (including interstitial pneumonia, pulmonary fibrosis, severe emphysema or atelectasis) and unsuitable for enrollment with the judgement of the investigator.
- •Malignant pleural effusion on the treatment side of lung.
- •Severe uncontrolled hypertension, diabetes, severe abnormal liver or kidney function, or heart failure that investigator assessed as unsuitable for enrollment.
- •Acute cardio-cerebrovascular events within 3 months, such as acute hemorrhagic or ischemic stroke, acute coronary syndrome, acute myocardial infarction.
- •Psychiatric disease that not well controlled.
- •With a history of recurrent tachyarrhythmia past 2 years. (Including rapid atrial arrhythmias, any rapid ventricular arrhythmias); or history of type II second-degree or III degree atrioventricular block or sinus bradycardia with heart rate < 45 beats/min, or sinus tachycardia > 120 beats/min.
- •Implanted electronic device in the body (such as pacemaker, implantable cardioverter defibrillator, or neurostimulator).
- •(it is acceptable If the implanted electronic device is allowed to be turned off during the procedure)
- •There is metal implants near the lesion to be ablated lesion (distance < 2-3cm) in the lung.
- •Patient is currently participating in another clinical trial.
- •Pregnant or breastfeeding women, or women planning to become pregnant during the study period.
- •Other situations judged by investigator as unsuitable for enrollment.
研究组 & 干预措施
Single arm
A non-thermal energy named pulsed electric field(PEF)
干预措施: Pulsed Electric Field Ablation (Device)
结局指标
主要结局
The clinical safety of the device and/or procedure in the operation of PEF ablation and entire study follow-up.
时间窗: Through 12 months
Adverse events rate and severe adverse event rate related to the device and/or procedure during the ablation procedure and thereafter 12 months follow-Up
次要结局
- The success rate of the ablation procedure(Once the procedure is completed.)
- The technical success rate of the PEF ablation(At 24-hour post the procedure)
- Complete ablation rate of the target lesions at 6-month and 12-month post the ablation.(At 6-month and 12-month)
- Proportion of patients with target tumor progression free survival (PFS) at 6-month and 12-month.(At 12 months)
- Overall Survival (OS) through 12 months.(At 12 months)