OCV-C01 as a combination therapy of peptide-based cancer vaccines for patients with advanced biliary tract cancer refractory to priortherapy : Phase II study
- Conditions
- advanced biliary tract cancer refractory to priortherapy
- Registration Number
- JPRN-UMIN000012778
- Lead Sponsor
- Kyushu University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Not provided
1) The patient have history of cancer immunotherapy. 2) Double cancer for less than one year, except cancer in situ or intramucosal cancer. 3) The primary disease has permeated and bleeding is strongly suspected. 4) Interstitial pneumonia or pulmonary fibrosis or past history. 5) Ascites fluid or pleural effusion with difficult control. 6) Pericardial effusion in need of puncture and discharge. 7) Serious infection or being suspected. 8) Brain metastasis or being suspected by clinical symptoms. 9) Serious mental disorder or serious neuropathy. 10) Cardiac disease, lung disease, renal disease, or liver disease that is difficult to control. 11) Grade 4 (CTCAE v4.0) or co-existing disease with poor control. 12) History of myocardial infarction, severe unstable angina pectoris, CABG, congestive heart failure, cerebrovascular accident, pulmonary embolism, deep-vein thrombosis, or other severe thromboembolism within 12 months before administration of OCV-C01. 13) Unhealed traumatic lesion, including traumatic fracture. 14) Evidence of bleeding diathesis or severe coagulopathy, or past histories. 15) Need continuous medication of antiplatelet drug except aspirin. 16) High blood pressure with poor control in spite of getting suitable medical treatment. 17) Heart failure that requires medical treatment. 18) Patients who require systemic administration of the following agents during the study treatment period. (1) Corticosteroid (2) Immunosuppresant, Immunostimulant (3) G-CSF, M-CSF (4) Erythropoietin 20) The result of HLA-A*24:02 has become clear beforehand. 21) Pregnant females, or nursing mothers who cannot stop lactation. Patient or patients partner unwilling to use adequate contraception during the study period and until 180 days after the last administration day for male, or until 120 days after the last administration day for female. 22) As determined by the principal investigator or the sub-investigator the subject are not adequate to participate in the trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method