JPRN-UMIN000027179已完成3 期
A double-blind, randomized clinical trial comparing S-1 in combination with DC vaccine loaded with WT1 peptides (TLP0-001) or placebo for the patients with advanced pancreatic cancer refractory to standard chemotherapy. - A double-blind, randomized clinical trial comparing S-1 in combination with DC vaccine loaded with WT1 peptides (TLP0-001) or placebo for the patients with advanced pancreatic cancer refractory to standard chemotherapy.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 185
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 79years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(1) Prior treatment of pyrimidine fluoride drug. (2) Prior treatment of Cancer immunotherapy. (3) Active double cancer (include asynchronous double cancer with disease-free duration <=1 year) except carcinoma in situ or intramucosal cancer. (4) Interstitial pneumonia or pulmonary fibrosis. (5) History of severe hypersensitivity to S-1 or its component. (6) History of hypersensitivity to OK-432, penicillin G, Gentamicin or streptomycin. (7) History of hypersensitivity to pig-derived or mouse derived component. (8) History of severe allergies (asthmaticus, anaphylactic shock etc). (9) Water diarrhea. (10) Cerebral metastasis or being suspected. (11) Pleural effusion, ascites fluid, or pericardial fluid in need of drainage. (12) Serious infections or being suspected. (13) Positive for serum anti-HBs Ag or HBV-DNA. (14) Positive for HCV Ab, HTLV1 Ab, HIV Ab, syphilis spirochete or parvovirus. (15) Severe nervous disorder or mental disorder. (16) Uncontrolled heart disease, pulmonary disease, kidney disease, or liver disease. (17) Complication of CTCAE Grade 4 or another uncontrolled complication. (18) Need continuous medication of flucytosine, phenytoin or warfarin. (19) Patients who require systemic administration of the following agents during the study treatment period. 1.Corticosteroid 2.Immunosuppresant, Immunostimulant 3.Erythropoietin (20) Autoimmune disease that needs treatment. (21) Test products can not be prepared to carry out at least one course (three times) from the autologous blood obtained by the apheresis performed before the secondary consent. (22) Current participation in other clinical trials. (23) Pregnant females or nursing mothers who can not stop lactation after the recruitment. Patients or partners, who don't attempt to doing contraception during the study period. (24) The subject who was determined by investigator that being not adequate to participate in the trial.
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