Unresectable Pancreatic Cancer
Conditions
Interventions
multicenter HLA-blinded study: patients will be vaccinated subcutaneously once a week with OCV-C01 and standard chemotherapy
Sponsors
Yamaguchi University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Invasive ductal carcinoma histologically confirmed of the pancreas. (2)Life expectancy > 3 months. (3)Patients must be >=20 years old (4)ECOG Performance Status must be 0 or 1. (5)Measureable region evaluable according to the RECIST(ver.1.1) (6)first line treatment (7)The following criteria must be satisfied in laboratory tests. 1) Hemoglobin >= 9.0 g/dL 2) White blood cell count >=3,500/mm3 <10,000 lymphocyte >=15% Neutrophil count >=2,000/mm3 3)Platelet count >=100,000mm3 4)Total bilirubin <=2.0 mg/dL 5)AST <=150 IU/L , ALT <=150 IU/L 6) Serum Creatinine <=1.5 mg/dL (8)Patients must have signed the consent form.
Exclusion criteria
Exclusion criteria: (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1year survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)overall survival 2)progression-free survival 3)Response rate 4)disease control rate 5)specific CTL response | — |
Countries
Japan
Contacts
Public ContactNobuaki Suzuki
Yamaguchi University Hospital Department of Surgery II
Outcome results
None listed