Exploratory trial of a combination therapy of mFolfirinox and immunotherapy against pancreatic cancer.
- Conditions
- Pancreatic cancer
- Registration Number
- JPRN-UMIN000026009
- Lead Sponsor
- Department of Gastroenterology and Hepatology, School of Medicine, Kochi University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 1
Not provided
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 or breast-feeding women 10)Patients with severe psychiatric diseases 11)Inappropriate patients for this study judged by the physicians.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse events of grade 3 or higher by the CTCAE criteria, Frequency of incidences at respective grade
- Secondary Outcome Measures
Name Time Method 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)