JPRN-jRCTs031180318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 - CAP-005
Ohtsuka Masayuki0 个研究点目标入组 40 人开始时间: 2019年3月18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 Nab-paclitaxel 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 (n = 15; 37.5%) events. In terms of efficacy of down-staging GnP therapy, R0 rate (as the primary endpoint) 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
- >= 20age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •1. Invasive ductal carcinoma or invasive intraductal papillary-mucinous carcinoma proved by radiological examination (enhanced CT or MRI)
- •2. No distant metastasis
- •3. Borderline or unresectable locally advanced pancreatic cancer tumor abutment of the SMA,CHA,CEA tumor involving PV or SMV diameter of encased PV or SMV are less than 50% of adjacent normal PV or SMV diameter.
- •4. patients who can tolerate the pancreatic surgery.
- •5. Age more than 20 or less than 80
- •6. No history of primary chemotherapy and/or radiation therapy.
- •7. ECOG performance status 0-1
- •8. Adequate organ function
- •9. Without problems for oral medication
- •10. Written informed consent
排除标准
- •1. History of severe 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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