JPRN-jRCTs061180045已完成1 期
The phase I,II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel+S-1 for patients with locally-advanced pancreatic cancer - The phase I/II study of neoadjuvant chemotherapy of GAS for locally-advanced pancreatic cancer
Kondo Naru0 个研究点目标入组 60 人开始时间: 2019年3月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
Phase 1: gemcitabine+nab-paclitaxel+S-1 chemotherapy showed good preliminary efficacy with mild toxicity in this study, and warrants a further phase 2 trial to investigate the efficacy of the gemcitabine+nab-paclitaxel+S-1 regimen for locally advanced pancreas cancer. Phase 2: The neoadjuvant GAS chemotherapy regimen for locally advanced pancreas cancer showed good efficacy with mild toxicity, resulting in a high R0 resection rate and prolonged survival in patients with locally advanced pancreas cancer.
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. Histologically confirmed pancreatic cancer
- •2. Locally advanced pancreatic cancer on imaging examinations
- •3. Performance status (ECOG): 0 or 1
- •4. Initial therapy
- •5. Agreement with signature of applicant has obtained before initiation of therapy
排除标准
- •(1)Severe allergy for medicine
- •(2)Patients with other malignant disease within 5 years
- •(3)Patients with active infection
- •(4)Patients with severe neuropathy (>Grade2)
- •(5)Patients with ileus
- •(6)Patients with interstitial pneumonia
- •(7)Patients with uncontrollable ascites or pleural fluid
- •(8)Patients with uncontrollable diabetes
- •(9)Patients with uncontrollable heart disease
- •(10)Patients with pregnant or possibly pregnant
- •(11)Patients who have judged not suitable for this study by doctor.
研究者
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