JPRN-UMIN000008082已完成2 期
Phase II study of Vaccination with Epitope peptides in combiNation with gemcitabine for UnreSectable Pancreatic Cancer - VENUS-PC study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
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
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(1) Prior treatment of peptide derived from KIF20A, VEGFR-1and VEGFR-2. (2) Prior immunotherapy for pancreatic cancer (3) Active double cancer (include asynchronous double cancer with disease-free duration <=1 year) except carcinoma in situ or intramucosal cancer. (4) Pancreatic cancer infiltrated into digestive tract with serious concern of bleeding. (5) Interstitial pneumonia or pulmonary fibrosis. (6) Cerebral metastasis or being suspected. (7) Pleural effusion, ascites fluid, or pericardial fluid in need of drainage. (8) Serious infections or being suspected. (9) Severe nervous disorder or mental disorder. (10)Uncontrolled heart disease, pulmonary disease, kidney disease, liver disease or another uncontrolled complication. (11)History of myocardial infarction, severe unstable angina pectoris, CABG, congestive heart failure, cerebrovascular accident, pulmonary embolism, deep-vein thrombosis, or other severe thromboembolism within 12 months before administration of OCV-C01 (12)Patients who require systemic administration of the following agents during the study treatment period. 1.Corticosteroid 2.Immunosuppresant, Immunostimulant (13)Current participation in other clinical trials. (14) patients who received unapproved drugs within two months. (15)Unhealed traumatic lesion, including traumatic fracture. (16)Evidence of bleeding diathesis or severe coagulopathy, or patients with those histories (17)Need continuous medication of antiplatelet drug except aspirin. (18)patients knows HLA-A type. (19)Pregnant females or nursing mothers who can not stop lactation after the recruitment. (20)Pregnant females or nursing mothers who can not stop lactation during the recruitment until 120 days after the last administration. (21)The subject who was determined by investigator that being not adequate to participate in the trial.
研究者
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