NCT04889989终止不适用
A Single-Arm, Prospective, Multicenter Study to Evaluate the Effectiveness and Safety of the NeuWave Certus Microwave Ablation System in Chinese Patients With Primary or Secondary Tumors in the Lung
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 8
- 主要终点
- Technical Efficacy Rate
研究概览
简要总结
Adult patients with non-small cell lung cancer (NSCLC) or oligometastatic lung tumors will all receive microwave ablation (MWA) performed percutaneously by doctors who are experienced in lung tumor ablation. 120 patients will participate across 8 clinical study sites all in China.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed the informed consent form and willing to fulfill the study-related assessments and procedure schedule.
- •Lung tumor patients ≥ 18 years of age who are ineligible for/decline surgery and who plan to receive microwave ablation therapy.
- •ECOG performance status score of 0-
- •Patients with stages IA1-IA2 NSCLC with documented results from a biopsy or patients with clinically diagnosed oligometastatic lung tumor.
- •Tumor(s) to be ablated in a single surgery should be a maximum of one NSCLC tumor or a maximum of three ipsilateral oligometastatic lung tumors.
- •Tumor(s) to be ablated in a single surgery should be ≤ 2cm, locate in the outer two-thirds of a lung, not closer than 1 cm from the hilum of lung, great vessels, principal bronchus, trachea or esophagus, and not contiguous with the pleura.
排除标准
- •Pregnant or breast-feeding.
- •Patients with implantable pacemakers or other electronic implants.
- •Oligometastatic tumors patients whose primary lesion cannot be controlled or have widely metastases, in the opinion of the investigator and/or treating oncologist.
- •Any planned concurrent procedure at the time of ablation.
- •Planned treatment for other tumors in the same side lung during the study period.
- •With a skin infection or ulceration at the site to be punctured by probe(s).
- •Clinical or imaging findings consistent with an active pulmonary infection.
- •Patients with severe pulmonary fibrosis in the area intended to ablate, especially drug-induced pulmonary fibrosis.
- •Patients with prior radiotherapy in the area intended to ablate.
- •Patients with uncontrolled malignant pleural effusion at the lung side with tumor to ablate.
- •Tumors where the anticipated zone of ablation would encompass significant (in the opinion of the treating physician) emphysematous or bullous disease.
- •The investigator anticipates that the ablation zone of the multiple tumor(s) to be ablated may have overlapping ablation zones.
- •Patients who have received lung ablation or surgical resection therapy within 30 days prior to the ablation procedure under study and those who plan to receive lung tumor ablation or surgical resection therapy or radiation therapy on the ablated lung side before completing the primary efficacy endpoint assessment approximately 30 days after the ablation procedure.
- •Patients who received systemic therapy such as chemotherapy, targeted drug therapy, or immunotherapy within 7 days prior to the ablation procedure under study, and patients who had a systemic treatment plan such as chemotherapy, targeted drug therapy, immunotherapy, etc. before completing the primary efficacy endpoint assessment approximately 30 days after the ablation procedure.
- •Patients with uncorrectable coagulopathy based on investigator judgment.
- •Patients with a platelet count ≤ 50 × 109/L.
- •Patients who cannot discontinue antiplatelet medication (e.g., aspirin, clopidogrel, prasugrel, ticagrelor) at least 5 days before the ablation procedure through 24 hours post-procedure.
- •Patients who cannot discontinue anticoagulant medication (e.g., rivaroxaban, apixaban, dabigatran, edoxaban) at least 3 days before the ablation procedure through 24 hours post-procedure.
- •Patients who cannot discontinue warfarin before at least 5 days before the ablation procedure of the study or have an INR > 1.
- •As judged by the investigator, the patient has hypertension that cannot be effectively controlled by pharmacological treatments.
- •Severe hepatic, renal, cardiac, pulmonary or cerebral insufficiency, severe anemia, dehydration, and severe nutrition and metabolism disorders, which cannot be corrected or improved within a short term; or serious systemic infection; or severe neuromuscular diseases.
- •Expected survival less than 6 months.
- •Participation in any other interventional clinical study within 30 days before screening.
- •Physical or psychological condition which would impair study participation.
- •Patient is judged unsuitable for study participation by the investigator for any other reason.
- •Intra-Ablation Exclusion Criteria:
- •Before ablation probe puncture on the skin, patient is judged unsuitable for study participation due to intolerance to anesthesia.
- •Before ablation probe puncture on the skin, patient is judged unsuitable for study participation due to presenting any other condition.
研究组 & 干预措施
Microwave Ablation of Lung Tumor
Other
Adult patients with non-small cell lung cancer (NSCLC) or oligometastatic lung tumors who plan to receive percutaneous microwave ablation.
干预措施: Microwave Ablation (Device)
结局指标
主要结局
Technical Efficacy Rate
时间窗: 30 days (+/- 7 days) post-ablation
Percentage of tumors that were completely covered by the ablation zone with no sign of pathological enhancement according to the lung contrast-enhanced CT assessment as assessed by the Independent Review Committee.
次要结局
- Technical Success Rate(Ablation Day (day 0))
- Local Tumor Progression(1 year post-ablation)
- Overall Survival(1-year post-ablation)
- Progression-Free Survival(1-year post-ablation)
研究者
研究点 (8)
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