advanced pancreatic and biliary tract cancers
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 injecte
Sponsors
Department of Internal medicine, Division of Gastroenterology and Hepatology, Kashiwa Hospital, Jikei University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosed as pancreatic or biliary tract cancer. 2. Informed about hisdiagnosis 3. 1) First-line treatment for inoperable patients. Stage IVa, IVb 2) Relase after operation Initial chemotherapy Two months after lastchemotherapy 4. HLA-A*2402 positive 5. Having evaluable disease by RECIST criteria 6. No chemotherapy/radiation/BRM has been performed. 7. Karnofsky Performance Status (KPS) over 50 8. Survival period is expected more than3 months 9. Meet the following criteria for organ functions 1)WBC more than4,000/microliter and less than 12,000,Neutrophil more than 2,000/microliter, Platelet moret han 100,000/microliter, Hemoglobin more than 9.5g/dl 2) Serum creatinine within normal limitation 3) Serum bilirubin less than1.5 folds of the upper normallimit 4) Serum AST/GOT less than 2.5 folds of the upper normallimit 5) Serum Albumin more than3.0g/dl 10. Pleural effusion, ascites and pericardial effusion are not detected orcontrolled. 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 fibrosis, 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 myelodysplastic 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 doctor's judged the patient inappropriate for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toxicities and adverse events are defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale. | — |
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 ContactShigeo Koido
Jikei University School of Medicine Division of Gastroenterology and Hepatology, Department of Internal Medicine
Outcome results
None listed