pancreas cancer
Conditions
Interventions
Administration of Gemcitabine Gemcitabine(1000mg/m2 )is administered via intravenous injection over 30min on day 1, 8, 15 of a 28-day cycle twice. WT1 vaccination The patient is intradermally inj
Sponsors
Department of Cancer immunotherapy, Osaka University Medical School
THE JIKEI UNIVERSITY
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosed as pancreas cancer. 2. Informed about his diagnosis 3. 1) First-line treatment for inoperable patients. Stage IVa, IVb 2) Relase after operation Initial chemotherapy Two months after last chemotherapy 4. HLA-A*2402 positive 5. Having evaluable diaseas by RECIST criteria 6. No chemotherapy/radiation/BRM has been performed. 7. Karnofsky Performance Status(KPS) over 50 8. Survival period is expected more than 3 months 9. Meet the following criteria for organ functions 1)WBC more than 4,000/microliter and less than 12,000,Neutrophil more than 2,000/microliter, Platelet more than 100,000/microliter, Hemoglobin more than 9.5g/dl 2) Serum creatinine within normal limitation 3) Serum bilirubin less than 1.5 folds of the upper normal limit 4) Serum AST/GOT less than 2.5 folds of the upper normal limit 5) Serum Albumin more than 3.0g/dl 10. Pleural effusion, ascites and pericardial effusion are not detected or controlled. 11. Informed consent has been obtained
Exclusion criteria
Exclusion criteria: 1. There is deep-seated active infection. 2,3 There are severe complications including malignant hypertention, cardiac failure, liver cirrhosis, severe DM, severe lung fiblosis, active interstitial pneumonitis.Patients who have complications that are considered inappropriate for the trial. 4. Dependent on total parenteral nutrition(TPN) 5. There are other malignancies. 6. There are hematopoietic stem cell disorders such as myelodisplastic syndorome(MDS) and myeloproliferative disorders (MPD). 7. Pregnant or lactating woman 8. Past history of severe drug allergy 9. There is severe psychiatric disorder. 10. Responsible doctors judged the patient inappropriate for the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Climical response rate Disease control rate Clinical benefit response 2. QOL outcomes 3. Immune responses to WT1 | — |
Countries
Japan
Contacts
Public ContactSumiyuki Nishida
Osaka University Medical School Department of Cancer Immunotherapy
Outcome results
None listed