Unresectable Advanced and Recurrent Pancreatic Cancer
Conditions
Sponsors
OncoTherapy Science, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Invasive pancreatic ductal carcinoma histologically confirmed as adenocarcinoma or squamous cell carcinoma 2)Unresectable pancreatic cancer which the UICC stage grouping is III or IV (including recurrent pancreatic cancer). Having of measurable lesions must not be required. The patient who has recurrent pancreatic cancer and had resection except palliative operation is excluded from this study, whether the persistency of local lesion. 3)Patients must have Histocompatibility Locus Antigen(HLA)-A*2402 4)Patients must be >=20 years old and <=80 years old at the time of consent. 5)ECOG Performance Status must be 0 or 1. 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 enrollment. -White blood cell count >=3,500 /mm3 ,<=12,000/mm3 -Neutrophil count >=2,000 /mm3 -Hemoglobin >= 9.0 g/dL -Platelet count >=100,000 /mm3 -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)Patients with no previous treatment (radiotherapy, chemotherapy, etc.) for pancreatic cancer, except resection. Previous treatment with radiotherapy, chemotherapy, etc. to the double cancer could be permitted, although the treatment must be conducted more than a year ago. 9)If the patient had laparotomy, it must be conducted 2 weeks or more before enrollment. 10)Patient must have signed the consent form.
Exclusion criteria
Exclusion criteria: 1)Prior treatment of OCV-101, OTS102 or KDR169 2)Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration to be within 1 year) except carcinoma in situ or intramucosal cancer 3)Pancreatic cancer infiltrated into digestive tract with serious concern of bleeding 4)Cerebral metastasis is doubted. 5)Moderate or greater pleural effusion, ascites fluid, pericardial fluid (requiring drainage). 6)Severe infections or being suspected. 7)Severe liver disorder or renal disorder, equivalent to CTCAE grade3 or greater. 8)Severe nervous disorder or mental disorder. 9)Uncontrolled diabetes mellitus. 10)Intestinal tract paralysis or being suspected. 11)Need chronic and systemic treatment of steroid. 12)Interstitial pneumonia or pulmonary fibrosis. 13)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-101. 14)Unhealed traumatic lesion, including traumatic fracture. 15)Evidence of bleeding diathesis or severe coagulopathy, or patients with those histories. 16)Need continuous medication of ant platelet drug except aspirin. 17)Uncontrolled hypertension. 18)Arrhythmia or heart failure that needs treatment. 19)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.). 20)Current participation in other drug clinical trials. (excluding the study, which doesn't need intervention) 21)Other serious complication. 22)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