liver cancer
Conditions
Interventions
personalized peptide vaccine plus best supportive care (BSC) ( total 8 times, every 1 weeks) Day 1: Select peptide candidates (up to 4), to which peptide-specific IgGs are detected before vaccinat
Sponsors
Kurume University Research Center for Innovative Cancer Therapy, Clinical Research Division
Hirosaki University , Fukusima prefectural medical University, Showa University, Kinki University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subjects must satisfy the following conditions. 1) HCV positive patients with standard therapy failed stage VI liver cancer. 2) Patients must be at a score level 0~1 of performance status (PS) (ECOG). 3) Patients must have IgG reactive to at least two of candidate peptides. 4)Patients in arm 1 must be positive for HLA-A2, -A24, -A26 or HLA-A3 super type(A3, A11, A31 or A33). 6) Patients must satisfy the followings: WBC is more than 2,000/mm3 Lymphocyte is more than 900/mm3 Hb is more than 8.0g/dl Platelet is more than 40,000/mm3 Serum Creatinine is less than 2.0mg/dl Total Bilirubin is less than 2.5mg/dl 6) Patients must be more 20 year-old. 7) Patients must be expected to survive more than 3 months. 8) Written informed consent must be obtained from patients. 9) Prior treatment are allowed and must complete before random assignment with full recovery of related toxicity.
Exclusion criteria
Exclusion criteria: The following patients must be excluded: 1) Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation). 2)Active double cancer (synchronous double cancer and metachronous double cancer within 5 disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment. 3) Patient who has doubt of immune deficiency disease or opportunistic infection. 4) Patients with the past history of severe allergic reactions. 2) Women during pregnancy or breast-feeding. 6) Patient of hepatic encephalopathy two degrees or more 7) Patients with brain metastasis. 8) Patients who are judged inappropriate for the clinical trial by doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of antitumor activity (overall survival) of peptide vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Evaluation of response rate and long-term prognosis (overall survival). 2.Adverse effects of peptide vaccination / The safety of the protocol is evaluated based on the NCI-CTCAE (v 4.0). 3.Evaluation of immunological responses (anti-peptide IgG) before and after peptide vaccination. | — |
Countries
Japan
Contacts
Public ContactAkira Yamada
Kurume University Research Center for Innovative Cancer Therapy, Cancer Vaccine Development Division
Outcome results
None listed