A multi-center double-blind parallel-group placebo-control Phase II study on the efficacy of survivin-2B peptide vaccine therapy for patients with advanced or recurrent pancreatic cancer, and for which there is no effective treatment

INTERVENTION: SVN‐2B(Placebo),STI‐01(Placebo) SVN‐2B,STI‐01(Placebo) SVN‐2B,STI‐01 CONDITION: Pancreatic cancer PRIMARY OUTCOME: Time to progression SECONDARY OUTCOME: 1)Immunological response; a)SVN‐2B peptide specific CTL number (Tetramer analysis); b)SVN‐2B peptide specific CTL activation(ELISPOT analysis); 2)Anti‐tumor effect based on RECIST guideline; 3)Safety; a)Adverse Effect; b)Laboratory Data INCLUSION CRITERIA: (1)Patients with a definitive diagnosis of pancreatic adenocarcinoma or invasive ductal carcinoma of pancreas. (2)Patients with expression of survivin protein in cancer cells. (3)Patients must meet all of the following criteria. a)Patients with inoperable status like distant metastasis, local recurrence or locally advanced cancer. b)Patients with cancer which did not respond or intolerable to gemcitabine or TS‐1. c)Patients who could not receive or refused to receive either gemcitabine or TS‐1. (4)Patients with measurable lesion based on RECIST as determined by CT or MRI at screening period. (5)Patients with HLA‐A*2402 positive. (6)Patients with ECOG Performance Status 0 or 1. (7)Patients without serious organ failure within 30 days prior to registration (neutrophil >=1,500/uL, hemoglobin level >=8.0 g/dL, platelet count >=75*103/uL, 1.5 times serum creatinine level <= normal upper limit level, 3 times total serum bilirub