resected pancreatic cancer
Conditions
Interventions
Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on days,1,8 and 15 for 24 weeks.
Sponsors
Second Department of Surgery, Wakayama Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Invasive pancreatic ductal carcinoma histologically confirmed as papillary adenocarcinoma, tubular adenocarcinoma, poorly differentiated adenocarcinoma or adenosquamous carcinoma of the pancreas. (2) Histologically confirmed R0 or R1 resected invasive pancreatic ductal carcinoma. (3) No recurrence (4) No Prior treatment for pancreatic cancer except surgical resection. (5) Patients must be >=20 years old and <=80 years old at the time of consent. (6) ECOG Performance Status must be 0 or 1. (7) The following criteria must be satisfied in laboratory tests. 1) White blood cell count >=3,500/mm3 2) Neutrophil count >=2,000/mm3 3) Hemoglobin >= 9.0 g/dL 4) Platelet count >=100,000mm3 5) Total bilirubin <=2.0 mg/dL 6) AST <=150 IU/L 7) ALT <=150 IU/L 8) Serum Creatinine <=1.5 mg/dL (8) No abnormal findings requiring treatment in the electrocardiogram within 21 days before enrollment. (9) Patients must be enrolled more than 2 weeks elapsed from resection of pancreatic cancer, not to exceed 10 weeks. (10) Patients must have signed the consent form.
Exclusion criteria
Exclusion criteria: (1) Interstitial pneumonia or pulmonary fibrosis. (2) Patients who require systemic administration of the following agents during the study treatment period. 1.Corticosteroid 2.Immunosuppresant, Immunostimulant (3) Active infections. (4) Severe complication (heart failure, renal failure, liver failure, bleeding from digestive ulcer, ileus,and uncontrolled diabetes) (5) Pleural effusion, ascites fluid, or pericardial fluid in need of drainage. (6) Active double cancer (include asynchronous double cancer with disease-free duration <=3 year) except carcinoma in situ or intramucosal cancer. (7) Prior treatment of peptide derived from KIF20A, VEGFR-1and VEGFR-2. (8) Prior cancer treatment except for pancreatic cancer (chemotherapy, hormone therapy, antibody therapy, radiation therapy, immunotherapy, and hyperthermia). (9) Severe mental disorder. (10) Sever drug-induced hypersensitivity (11) Unhealed traumatic lesion, including traumatic fracture. (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) Need continuous medication of antiplatelet drug except aspirin. (14) Uncontrolled hypertension. (15) Heart failure and arrhythmia that needs treatment. (16) Aneurysms and varices with serious concern of bleeding. (17) Current participation in other clinical trials. (18) 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.). (19) Pregnant females or nursing mothers who can not stop lactation during the recruitment until 120 days after the last administration. (20) The subject who was determined by investigator that being not adequate to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease-free survival | — |
Countries
Japan
Contacts
Public ContactMotoki Miyazawa
Wakayama Medical University Second Department of Surgery
Outcome results
None listed