Phase II clinical trial of personalized peptide vaccination for liver cancer patients

INTERVENTION: <1st treatment: total 8 times, which include weekly injection for 4 times followed by bi‐weekly injection for 4 times> Select vaccine peptides (up to 4) from 31 candidate peptides , to which peptide‐specific IgGs are detected before vaccination. Individually emulsify these peptides with IFA and subcutaneously inject (3.0 mg/peptide). CONDITION: liver cancer PRIMARY OUTCOME: Evaluation of immune responses (anti‐peptide IgG) before and after personalized peptide vaccination. SECONDARY OUTCOME: 1. Evaluation of long‐term prognosis (progression free survival and overall survival).; ; 2. Adverse events of personalized peptide vaccination. Adverse events are evaluated by the NCI‐CTCAE. INCLUSION CRITERIA: The subjects must be satisfactory the following conditions. 1) patients must be diagnosed as grade III or IV liver cancer. Presence of target legion, former treatment, and disease stage are not considered. 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 must be expected to survive more than 3 months. 5) Patients must satisfy the followings. WBC is more than 2500 per mm3 Lymphocyte is more than 900 per mm3 Hb is more than 8.0 g per dL Platelet is more than 50000 per mm3 Serum creatinine is less than 2.0 mg per dL Total bilirubin is less than 2.5 mg per dL 6) patients must be more than 18 years old. 7) written informed consent must be obtained from patients. 8) patients must be positive for HLA‐A2, A24, A26, A3, A11, A31 or A33.