JPRN-jRCT1041200082招募中2 期
A randomized phase II study comparing liposomal irinotecan + fluorouracil + levofolinate to FOLFIRINOX as second-line chemotherapy for pancreatic cancer (NUPAT-09 trial)
Maeda Osamu0 个研究点目标入组 40 人开始时间: 2020年12月24日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Advanced or recurrent pancreatic cancer treated with primary chemotherapy including gemcitabine
- •2. ECOG performance status 0 or 1
- •3. Neutrophil count >= 2,000/mm3
- •4. Platelet count >= 100,000/mm3
- •5. Total bilirubin >= upper limit of normal x 1.5
排除标准
- •1. Complications of infectious diseases
- •2. Serious cardiac disease or a history of such disease
- •3. Intestinal paralysis or intestinal obstruction
- •4. Interstitial pneumonia or pulmonary fibrosis
- •5. Massive ascites or pleural effusions
- •6. Severe dysesthesia or sensory deficiency with functional impairment
- •7. A history of hypersensitivity to oxaliplatin or other platinum-containing drugs, irinotecan, liposomal irinotecan, fluorouracil, or levofolinate.
- •8. Pregnant women or women who may be pregnant
- •9. Patients on atazanavir sulfate
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