Non curative pancreas cancer
Conditions
Interventions
The single intratumoral administration of Nek2 siRNA in pancreatic cancer
Sponsors
Nagoya University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Non curative pancreas cancer 2) Patients must be 20-84 years old 3) The long axis of target legion must be>=10 mm, and the maximum tumor volume must be<=25.2 cm3 4) Patients must have performance status of 0-2 on the ECOG (Eastern Oncology Group) scale. 5) The following criteria must be satisfied in laboratory tests 1.White blood cell count >=2,000/microL 2.Hemoglobin >=9.0 g/dL 3.Platelet count >=75,000/ microL 4.Total bilirubin <=3.0 mg/dL 5.AST<=150 IU/L 6.ALT<=150 IU/L 7. Creatinine <=1.5 mg/dL 6) Life expectancy >=3 months 7) Patients must be informed of the investigational nature of this study and must give written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients who have acquired, hereditary, or congenital immunodeficiency or being suspected 2) Patients have active, uncontrolled infections or being suspected 3) Patients have serious complication 4) Pregnant women or being suspected, nursing women and women of child-bearing potential, disagree to use adequate contraception 5) Patients have clinically significant and uncontrolled medical condition, considered a high risk for participation in an investigational research study 6) Patients have a medical condition contraindicated for the atelocollagen and contrast agents 7) Patients have participated in any clinical research study within the last 3 weeks. 8) Patients have received immunotherapy for cancer within the last 3 months 9) Patients have history of a second active malignancy at the time of pre-study screening 10) Patients have positive human immunodeficiency virus (HIV) or Hepatitis C antibodies (HCV) or Hepatitis B anti-core antibodies (HBV). 11) In the opinion of the principal or associate investigators, it is not in the best medical interest of the patients to enter this study, the patients will not be eligible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with adverse events through 28 days, as a measure of safety and tolerability using CTCAE ver4.0 criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| The overall objective clinical response rate will involve CT assessment of pancreas cancer, compared with baseline CT measurement using RECIST criteria. Overall response, progression-free survival and overall survival are assessed to determine the clinical benefit. | — |
Countries
Japan
Contacts
Public ContactToshio Kokuryo
Nagoya University Graduate School of Medicine Division of Surgical Oncology
Outcome results
None listed