JPRN-jRCTs051200029招募中2 期
A double-blind randomized phase II study of AHCC for patients with resectable / borderline resectable pancreatic cancer - Phase II study of AHCC for pancreatic cancer
Satoi Sohei0 个研究点目标入组 230 人开始时间: 2020年6月25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
- 230
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.Histologically proven invasive ductal carcinoma of the pancreas (adenocarcinoma, adenosquamous carcinoma), resectable (R) or borderline resectable (BR-A, BR-V) in General Rules for the Study of Pancreatic Cancer (the 7th Edition)
- •2.Patients who undergo preoperative chemotherapy
- •3.Eastern Cooperative Oncology Group performance status of 0 or 1
- •4.Adequate bone marrow, liver, and kidney function in measurements taken within 14 days before registration (leucocyte count >= 3000 cells per mm3 and <= 12 000 cells per mm3; leucocyte count >= 2000 cells per mm3; haemoglobin concentration >= 8.0 g/dL; platelet count >= 100 000 cells per mm3; total bilirubin <= 2.0 mg/dL (3.0 mg/dL for patients with biliary stent); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) concentrations <= 150 IU/L; serum creatinine concentrations <= 1.2 mg/dL; creatinine clearance >= 50mL/min
- •5.Possibility of adequate oral intake
- •6.Provide written informed consent
- •7.Be aged 20 years or older with sufficient judgement
排除标准
- •1.Unresectable pancreatic cancer (UP-M) due to distant metastasis (eg, distant lymph nodes, liver, peritoneal dissemination, lung, pleural dissemination, brain, and bone) in General Rules for the Study of Pancreatic Cancer (the 7th Edition)
- •2.Local advanced unresectable pancreatic cancer (UP-LA) in General Rules for the Study of Pancreatic Cancer (the 7th Edition)
- •3.Already treated for pancreatic cancer before registration with such as chemotherapy, radiation, or immune therapy
- •4.Patients who undergo surgery without preoperative chemotherapy (up-front surgery)
- •5.Serious drug allergy to S-1, gemcitabine, nab-paclitaxel, paclitaxel, oxaliplatin, irinotecan, leucovorin, or fluorouracil
- •6.Active infectious disease (eg, pyrexia of 38 degrees of body temperature or higher)
- •7.Had other serious complications (eg, heart failure, kidney failure, pulmonary failure, or liver failure, uncontrollable diabetes)
- •8.Gastrointestinal bleeding which needs repeated blood transfusion
- •9.Inadequately controlled watery diarrhea
- •10.Complicating psychiatric disorder or psychological symptoms
- •11.Active multiple primary cancers
- •12.Pregnant, breastfeeding, childbearing potential, or willing to bear children
- •13.Receiving flucytosine, phenytoin, or warfarin potassium
- •14.Unable to provide written informed consent
研究者
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