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.
- Conditions
- pancreatic cancer
- Registration Number
- JPRN-UMIN000027179
- Lead Sponsor
- Wakayama Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 185
Not provided
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method Progression free survival Response rate Adverse events Rate of dose limiting toxicity (first six patients in active group)