liver cancer
Conditions
Interventions
Arm 1: personalized peptide vaccine plus best supportive care (BSC) (1st treatment: total 8 times, every 1 weeks) Day 1: Select peptide candidates (up to 4), to which peptide-specific IgGs are dete
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 be satisfactory 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 ECOG performance status. 3) patients must have IgGs reactive to at least two of candidate peptides belongs to an apropriate group(s) for patient's HLA types. 4) Patients in arm 1 must be positive for HLA-A2, -A24, -A26 or HLA-A3 super type(A3, A11, A31 or A33). 5) Patients must satisfy the followings. WBC is more than 2500 per mm3 Lymphocyte is more than 1000 per mm3 Hb is more than 8.0 g per dL Platelet is more than 80000 per mm3 Serum creatinine is less than 2.0 mg/dl Total bilirubin is less than 2.5 mg/dl 6) patients must be more than 20 years 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) Patients with the past history of severe allergic reactions. 3) Patients who are during pregnancy, lactation expectant, and desiring future fertility. 4) 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