EUCTR2016-001332-35-NL进行中（未招募）1 期
A nationwide open-label multi-center prospective cohort study of nab-paclitaxel plus gemcitabine in patients with locally advanced pancreatic cancer - NABGEM prospective cohort study in LAPC
Academic Medical Center Amsterdam0 个研究点开始时间: 2017年1月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Written informed consent according to ICH/GCP, and national/local regulations prior to any screening procedures.
- •Histological or cytological confirmed diagnosis of pancreatic ductal adenocarcinoma.
- •Locally advanced pancreatic cancer according to DPCG criteria (SMA, celiac axis or CHA contact >90° or SMV-PV contact <270° or occlusion) 28
- •ECOG (WHO) performance status 0-2
- •Age = 18 years
- •Adequate bone marrow and organ function as defined by the following laboratory values:
- •Absolute neutrophil count (ANC) = 1.5 *109 / L
- •Hemoglobin (Hb) = 9.0 g/dL (5.6 mmol/L)
- •Platelets = 100 *109/L
- •Serum total bilirubin within = 1.5 x ULN (upper limit of normal); or total bilirubin < 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert’s syndrome.
- •Creatinine clearance > 50 ml / min / 1.73 m2
- •AST and ALT < 2.5 ULN
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 56
排除标准
- •WHO performance status = 3
- •Distant metastases on abdominal or thoracic CT scan.*
- •Previous surgical, local ablative, chemotherapy or radiotherapy for pancreatic cancer except for a surgical exploration with no options for resection.
- •Pregnancy
- •Patients who in the investigators’ opinion may be unwilling, unable or unlikely to comply with requirements of the study protocol
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