Antiangiogenic Peptide Vaccine Therapy in Treating Patient With Hepatocellular Carcinoma

Phase 1 Study of HLA-A*2402 Restricted Antiangiogenic Peptide Vaccine Therapy Using Epitope Peptide Derived Feom VEGFR1 and VEGFR2 in Treating Patients With Unresectable, Recurrent, or Metastatic Hepatocellular Carcinoma

The purpose of this study is to assess toxicities of angiogenic peptide vaccine therapy in treating HLA-A*2402 restricted patients with advanced hepatocellular carcinoma.

It has been required to develop new treatment modalities for patients with advanced heptatocellular carcinoma. Immunotherapy is one of the encouraging modalities for patients. We have to assess its toxicities, clinical response and immune responsiveness.

Inclusion Criteria:

• Unresectable or treatment-resistant patients with Hepatocellular carcinoma
• Measurable disease by CT scan
• ECOG performance status 0-2
• Life expectancy > 3 months
• Laboratory values as follows: 2,000/mm3 < WBC <15,000/mm3, Platelet counts > 75,000/mm3, Total Bilirubin < 1.5 mg/dl, Asparate transaminase < 150IU/L, Alanine transaminase < 150 IU/L, Creatinine < 3.0mg/dl
• HLA-A*2402
• Able and willing to give valid written informed consent

Exclusion Criteria:

• Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
• Brest-feeder
• Active or uncontrolled infection
• Steroids or immunosuppressing agent dependent status
• Active or uncontrolled other malignancy
• Serious or uncured wound
• Decision of unsuitableness by principal investigator or physician-in charge