pancreatic cancer
Conditions
Interventions
A combined chemoimmunotherapy of Gemcitabine and S1 plus WT1-W10 peptide vaccine
Sponsors
Department of Gastroenterology and Hepatology, School of Medicine, Kochi University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) pancreatic cancer patients diagnosed by pathological examination 2) patients who have been informed about the disease 3) patients who are treated with chemotherapy using Gemcitabine as a single agent 4) The overexpression of WT1 in the tumor has been observed by immunohistochemical staining. 5) patients bearing one or two of HLA-A*24:02, A*02:01, A*02:06, or A*02:07 genes 6) 20 years of age or older, but less than 80 years 7) The performance status should be between 0-2 by the ECOG criteria 8) Function of major organs have been maintained. Results of the clinical tests are within the following limits. Neutrophil >= 1,000/ul Platelets >= 40,000ul Hemoglobin(Hb) >= 8g /dL Serum bilirubin =< x3 of upper limit of normal(ULN) AST and ALT =< x3 of ULN Serum albumin >= 2.5g/dL Serum creatinin =< 1.5mg/dL ECG: no serious irregularities Sp02 >= 94% (while breathing ambient air) 9) life expectancy > 4 months 10) Patient from whom a written consent is obtained.
Exclusion criteria
Exclusion criteria: 1) Patients with uncontrollable infectious diseases (including active Tuberculosis) 2) patients with severe complications (malignant lypertension, severe congestive heart failure, severe colonary in sufficiency, myocardial, infarction within three months, terminal, stage of liver cirrhousis, uncontrollable diabetes mellitus, severe pulmonary fibrosis, active interstitial pneumonitis, etc.) 3) patients with serious comorbidities (generally those of NCI-CTC ver 3.0 grade 3 or higher) 4) patients who have been under parenteral nutrition for more than 24 hours due to impairment of digestive organs. 5) liver metastasis occupying more than 1/3 of the liver 6) Patients with active concomitant malignancy 7) patients with hematopoietic malignancies including MDS, MDS/MPD, CML 8) patients who have received bone marrow or hematopoietic stem cell transplantation 9) pregnant women, breast feeding mothers 10) patients with serious psychological disorders 11) patients whose participation to the study is considered inappropriate by the doctors for various reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events of grade 3 or higher by the CTCAE criteria, Frequency of incidences at respective grade | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of WT1 W10-specific CD8 T cells, DTH (delayed-type hypersensitivity at injection sites), measurement of the tumor size, immunohistochemistry of the tumor (if tumor tissue is obtained) | — |
Countries
Japan
Contacts
Public ContactKeiko Udaka
School of Medicine, Kochi University Anti-tumor Immunotherapy Research Network, Central Office, Department of Immunology
Outcome results
None listed