Simultaneous Gemcitabine and Irreversible Electroporation for Locally Advanced Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Safety (number of adverse effects)
研究概览
简要总结
The aim of this study was to compare the therapeutic efficacy between simultaneous gemcitabine administration and IRE and IRE alone for locally advanced pancreatic cancer (LAPC)
详细描述
in the GEM- IRE group, before the IRE ablation started, patients received 1000 mg/m2 gemcitabine hydrochloride [Qilu pharmaceutical (Hainan) Co., Ltd. Haikou, China] intravenously (over approximately 30 min).
In the IRE group, the IRE ablation was performed without gemcitabine intravenous infusion before IRE.
The aim of this study was to evslusted the overall survival (OS), objective response rate (ORR) and adverse events after simultaneous therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radiologic confirmation of unresectable locally advanced pancreatic cancer by at least CT of chest and abdomen
- •Screening must be performed no longer than 2 weeks prior to study inclusion
- •Maximum tumor diameter ≤ 5 cm
- •Histological or cytological confirmation of pancreatic adenocarcinoma;
- •Age ≥ 18 years
- •PS-classification 0 - 2
- •Life expectancy of at least 12 weeks
- •Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to definite inclusion;
- •Hemoglobin level ≥ 115 g/L
- •Platelet count ≥ 100*109/l
- •Neutrophil count ≥ 2×109/L;
- •White blood cell count ≥ 4 ×109/L;
- •ALT and AST ≤ 2.5 x ULN
- •Serum creatinine ≤ 1.5 x ULN or a calculated creatinine clearance ≥ 50 ml/min
- •Prothrombin time or INR < 1.5 x ULN
- •Written informed consent
排除标准
- •Resectable pancreatic adenocarcinoma as discussed by our multidisciplinary hepatobiliary team
- •History of epilepsy
- •History of cardiac disease:
- •Cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker (beta blockers for antihypertensive regimen are permitted)
- •Compromised liver function (e.g. signs of portal hypertension, INR > 1,5 without use of anticoagulants, ascites)
- •Uncontrolled infections (> grade 2 NCI-CTC version 3.0)
- •Pregnant. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment
- •Allergy to contrast media
- •Any implanted stimulation device
- •Any implanted metal stent/device within the area of ablation that cannot be removed
研究组 & 干预措施
simultaneous gemcitabine and irreversible electroporation
gemcitabine intravenous infusion prior to irreversible electroporation treatment.
干预措施: simultaneous gemcitabine and irreversible electroporation (Procedure)
IRE group
percutaneous irreversible electroporation for locally advanced pancreatic cancer.
干预措施: irreversible electroporation (Procedure)
结局指标
主要结局
Safety (number of adverse effects)
时间窗: 3 month
Adverse events
次要结局
- Tumor response(12 months)
- Overall survival (OS)(36 months)
- Carbohydrate antigen 19-9 (CA19-9)(1 month)
- Technical success of ablation(3 months)