Breast cancer, colorectal cancer, pancreatic cancer, gastric cancer, lung cancer Breast cancer, colorectal cancer, pancreatic cancer, gastric cancer, lung cancer
Conditions
Interventions
Dendritic cell-based cancer vaccination
Cancer, dendritic cell, vaccination
Sponsors
Shimodaira Shigetaka
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age at the time of informed consent: 20 to 75 years old 2. Performance status: 0/1 3. Pathological diagnosis: WT1 positive adenocarcinoma 4. Adjuvant therapy after surgical resection 5. Neither cardiovascular diseases nor respiratory disorders that would prevent blood apheresis 6. No organ function abnormalities, no blood abnormalities, no bleeding tendency 7. No infectious diseases 8. Understand the risk and benefit of the dendritic cell-vaccination 9. No other clinical trials
Exclusion criteria
Exclusion criteria: 1. Allergy to penicillin or OK-432 2. Advanced diseases such as obstructive jaundice and involvement either in pleura or in peritoneum 3. Requiring platelet or red blood cell transfusion or albumin infusion 4. Disseminated intravascular coagulation syndrome and deep vein thrombosis 5. An infectious disease such as viral hepatitis (following the standard of the Japanese Red Cross Blood Center) 6. Past history of cerebrovascular disorders such as cerebral hemorrhage and infarction 7. Poor control of lung diseases such as chronic obstructive lung disease, bronchial asthma, and requiring oxygen dosage 8. Pneumonitis (the past) 9. Autoimmune diseases (present or the past) 10. Steroid hormone therapy continuously administered for diseases other than the prevention of temporal chemotherapeutic drug allergy 11. Mental disease (including neurosis, the panic disorder) 12. The past of epilepsy having poor control 13. Difficulty in arm vessel blood access for apheresis 14. No informed consent due to cancer 15. Inability to understand the risk and benefit of the DC vaccination 16. Pregnant or nursing women, desire to bear children 17. Under the treatment with immune checkpoint inhibitors during this clinical trial 18. Under the radiotherapy during this clinical trial 19. Physician judgment that a patient is inappropriate for treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (adverse reactions, severe adverse events) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. One and 2 years survival ratio 2. Progression free survival at the 1 and 2 years 3. WT1-specific immunoresponse 4. DTH (delayed type hypersensitivity reactionreaction) 5. QOL maintenance 6. Tumor marker 7. Monitoring of the biomarker (the measurement such as WT1mRNA, ctDNA, PD-L1) | — |
Countries
Japan
Contacts
Public ContactKenichi Yoshida
Kanazawa Medical University Hospital
Outcome results
None listed