ACTRN12621000955819招募中未知
Investigation of the safety and efficacy of irreversible electroporation (IRE) using the NanoKnife® System in patients with unresectable stage 3 pancreatic cancer who have received 3 months of chemotherapy (DIRECT/InspIRE Australia)
Walter & Eliza Hall Institute of Medical Research (WEHI)0 个研究点目标入组 20 人开始时间: 2021年7月21日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1 Patient has a diagnosis of unresectable Stage 3 pancreatic ductal adenocarcinoma cancer cytologically or pathologically confirmed as per American Joint Committee on Cancer (AJCC) staging criteria.
- •2 Patient is newly diagnosed and has only received a single line of therapy for at least 3 months prior to enrolment. They must have received either modified FOLFIRINOX or gemcitabine-based chemotherapy.
- •3 Patient has a tumour evaluated as Stage 3 according to National Comprehensive Cancer Network (NCCN) guidelines, based on radiographic imaging or exploratory surgery.
- •4 Maximum axial tumour dimension of less than or equal to 3.5cm, after receiving at least three months of treatment with a modified FOLFIRINOX or gemcitabine-based regimen.
- •5 Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •6 Patient has an American Society of Anaesthesiologists (ASA) classification of physical health status of 1 or 2.
排除标准
- •1 Patients who at 3 months after induction chemotherapy have evidence of disease progression.
- •2 Patients who have undergone prior radiation therapy or surgical resection for treatment of pancreatic cancer.
- •3 Patients who have received IRE for margin accentuation.
- •4 Patients who are unable to tolerate general anaesthetic with full skeletal muscle blockade.
- •5 History of another primary cancer within the last 3 years, with the exception of non-melanomatous skin cancer and carcinoma in-situ.
- •6 Patients who are actively bleeding, anticoagulated, coagulopathy, or have any of the following haematology results:
- •a.Haemoglobin <100 g/L without the support of growth factors or transfusion
- •b.Absolute neutrophil count <1.5 x 109/L
- •c.Platelet count <100 x 109/L
- •7 Patients with the presence of implanted cardiac pacemakers, defibrillators, electronic devices or implanted devices with metal parts in the thoracic cavity at the time of IRE.
- •8 Patients with history of epilepsy or other neurological disease.
- •9 Patients with inadequate organ function:
- •a.Patients with Stage 3 (GFR 30 to 44ml/min), 4 (15 to 29ml/min), or 5 (<15ml/min) chronic kidney disease.
- •b.Aspartate aminotransferase/alanine aminotransferase >2.5 x upper limit of normal.
- •c.Clinically significant cardiovascular disease i.e. active or <12 months since e.g. cerebrovascular accident, myocardial infraction, unstable angina, New York Heart Association grade II or greater congestive heart failure, serious cardiac arrhythmias requiring medications, uncontrolled hypertension.
- •10 Patients who are pregnant or breastfeeding. Women of childbearing potential (WOCBP) must undergo pregnancy testing.
研究者
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