JPRN-jRCTs061180009招募中2 期
The phase 2 study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel+S-1 for patients with biological borderline resectable pancreatic cancer. - The phase 2 study GAS for biological borderline resectable pancreatic cancer
emura Kenichiro0 个研究点目标入组 50 人开始时间: 2018年12月7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
- 50
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 <= 80age old（—）
- 性别
- All
入选标准
- •(1) A histologically or cytologically proven diagnosis of adenocarcinoma or adenosquamous carcinoma
- •(2) No distant metastasis
- •(3) Tumor with no contact with the major arteries including the superior mesenteric artery, celiac artery, or common hepatic artery on pretreatment computed tomography (CT)
- •(4) Tumor with no contact or less than 180 degrees contact with portal vein
- •(5) More than 100 U/ml of pretreatment serum CA19-9 level
- •(6) Initial treatment
- •(7) 0 or 1 of Performance status (ECOG)
- •(8) Age between 20 and 79
- •(9) Adequate hematological, hepatic, and renal functions by hemoglobin >=9.0 g/dl, leucocytes >=3,000 /mm2 and =<12,000 /mm2, neutrophils >=1,500 /mm2, platelets >=100,000 /mm2, total bilirubin =<2.0mg/dl, aspartate aminotransferase and alanine aminotransferase =(10)The willingness to sign a written informed consent before registration
排除标准
- •1.Severe allergy for protocol drugs
- •2.History of active malignant disease within 5 years
- •3.Active infectious disease
- •4.More than Grade2 of neuropathy
- •6.Active interstitional pneumonia
- •7.Uncontrolable ascites and pleural effusion
- •8.Uncontrolable diabetes
- •9.Uncontrolable heart diseases
- •10.History of sevese neurological diseases
- •11.Severe diarrhea
- •12.Pregnancy or possibility of pregnancy
- •13.Others who were judged to be not appreciated for participation to this clinical trial by attending physician
研究者
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