JPRN-UMIN000022241已完成2 期
A phase II trial of Down staging Chemotherapy with Nab-paclitaxel plus Gemcitabine in patients with locally advanced pancreatic cancer - A phase II trial of GnP down staging chemotherapy for patients with locally advanced pancreatic cancer (CAP-005)
Chiba study group of adjuvant chemotherapy for pancreatic cancer0 个研究点目标入组 40 人开始时间: 2016年5月8日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
A phase II trial of Down staging Chemotherapy with nabPTX plus Gemcitabine in patients with locally advanced pancreatic cancer was conducted. Of all 40 participants, the G3/4 toxicity was occurred in 19 patients (47.5%). In terms of hematological toxicity, neutropenia was commonly noted for grade 3/4 (37.5%) events. In terms of efficacy of down-staging GnP therapy, R0 resection rate was 55.0% in the FAS, 77.8% in the resected cases, and 87.0% in the on-protocol cohort.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 80years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1)History of sever allergic reaction with gemcitabine, nab-paclitaxel or S-1 2)Pregnant females, possibly pregnant females, females wishing to become pregnant, and females feeding babies. 3)Pulmonary fibrosis or interstitial pneumonia 4)History of breast or lung radiation 5)Active infection 6)Patients with pleural effusion 7)Active double cancer 8)Patients with positive for HBs antigen 9)Patients under treatment with phenytoin or walfarin 10)Uncontrolled heart diseases such as angina, myocardial infarction within three months, and cardiac dysfunction 11)Uncontrolled diabetes or hypertension 12)Sever mental disorder 13)Inadequate physical condition, as diagnosed by primary physician
研究者
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