NL-OMON46852已完成2 期
A nationwide open-label multi-center prospective cohort study of nab-paclitaxel plus gemcitabine in patients with locally advanced pancreatic cancer - NABGEM studie
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
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)
- •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
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
研究者
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