Pancreatic cancer refractory to standard therapy
Conditions
Interventions
OCV-C01 1mL will be administered once a week as 1 treatment course for every 4 weeks, until patient'
s condition meets withdrawal criteria.
Placebo 1mL will be administered once a week as 1 treatment course for every 4 weeks, until patient'
Sponsors
OncoTherapy Science, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Invasive pancreatic ductal carcinoma histologically or cytologically confirmed as adenocarcinoma or squamous cell carcinoma. Presence of measurable disease is not considered. (2) Refractory to standard therapy. -Patient must have treated by Gemcitabine at least one time. -It doesn't matter weather patient had treated by another antitumor drug or radiation therapy. (3) Patients must be >=20 years old and <=80 years old at the time of consent. (4) Karnofsky Performance Status must be >=80. (5) Patients must have Human Leukocyte Antigen (HLA)-A*24:02. (6) Life Expectancy must be >=3 months. (7) The following criteria must be satisfied in laboratory tests conducted within 21 days before enrollment. And G-CSF, Erythropoetin, Blood products and transfusion must be untried within 21days before laboratory tests. -White blood cell count >=2,000/mm3 ,<=12,000/mm3 -Neutrophil count >=1,500/mm3 -Hemoglobin >= 9.0 g/dL -Platelet count >=75,000mm3 -Total bilirubin <=2.0 mg/dL(to be permitted <=3.0 mg/dL in patients treated by biliary drainage for obstructive jaundice) -AST <=150 IU/L -ALT <=150 IU/L -Serum Creatinine <=1.5 mg/dL (8) The period from the end of previous treatment to the beginning of this trial must be satisfied following criteria. -antitumor drug : >=15days -domestic unrecognized drug which has anti-tumor effect. : >=29days antibody drug : >=57days -radiotherapy : >=29days - laparotomy: >=15days - systemic treatment of corticosteroid: >=15days (9) Patient must have signed the consent form
Exclusion criteria
Exclusion criteria: (1) Prior treatment of peptide derived from KIF20A, VEGFR-1and VEGFR-2. (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) 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, or liver disease. (11) Complication of Grade 4 or another uncontrolled complication. (12) 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 (13) Unhealed traumatic lesion, including traumatic fracture (14) Evidence of bleeding diathesis or severe coagulopathy, or patients with those histories (15) Need continuous medication of antiplatelet drug except aspirin. (16) Uncontrolled hypertension. (17) Heart failure that needs treatment. (18) Patients who require systemic administration of the following agents during the study treatment period. 1.Corticosteroid 2.Immunosuppresant, Immunostimulant 3.G-CSF 4.Erythropoietin (19) Current participation in other clinical trials. (20) 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 (during the study period and until 180 days after the last administration day for male, or until 120 days after the last administration day for female.). (21) The subject who was determined by investigator that being not adequate to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | — |
Countries
Japan
Outcome results
None listed