advanced biliary tract cancer refractory to priortherapy
Conditions
Interventions
OCV-C01 by 1.0 mL/body will be administrated subcutaneously once per week to an axillary region or the inguinal region by making medication into one course for four weeks. When an axillary region or
The medication stop standard established"
separately. The last medication day is set up from a medication opening day to the 365th by the longest.
Sponsors
Kyushu University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosed as a biliary tract cancer (carcinoma of the intrahepatic bile duct (IHBD), the extrahepatic bile duct (EHBD), the gallbladder (GB), or the ampulla of Vater (AV). 2) Histologically proven adenocarcinoma or adenosquamous carcinoma for patients with EHBD, GB, or AV carcinomas, or adenocarcinoma for IHBD carcinomas. Presence of measurable disease is not considered. 3) Unresectable biliary tract cancer designated as stage II - IV. 4) Refractory or not tolerated to the regimens containing gemcitabine. 5) Extension of a survival period is not expectable with radiotherapy. 6) Performance Status (ECOG) is 0 or 1. 7) The age at the time of consent acquisition is aged 20 and over. 8) Main internal-organs functions are held and following condition are met. (1) white blood count >=2,000 /cmm (2) neutrophils >=1,000 >/cmm (3) hemoglobin >=8.0 g/dL (4) platelets 5.0x104 /cmm (5) AST<=200 IU/L (6) ALT<=200 IU/L (7) serum creatinine <=1.5 mg/dL (8) Investigators judgment, there is no event it becomes difficult to administrate a medicine for the patient. 9) Written informed concent for this clinical trial is obtained by the patient.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Progression free survival (PFS) 2) Response rate 3) Disease control rate 4) Adverse events 5) Serious adverse events 6) Biomakers (specific CTL respnse, etc) | — |
Countries
Japan
Contacts
Public ContactToshihisa Tsuruta
Kyushu University Hospital Department of Advanced Molecular and Cell Therapy
Outcome results
None listed