Antiangiogenic Peptide Vaccine Therapy in Treating Patient With Hepatocellular Carcinoma
Phase 1
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Biological: antiangiogenic paptide vaccine
- Registration Number
- NCT01266707
- Lead Sponsor
- Fukushima Medical University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 9
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vaccine antiangiogenic paptide vaccine VEGRF1, VEGFR2
- Primary Outcome Measures
Name Time Method Toxicities as assessed by NCI-CACAE ver3 3 months
- Secondary Outcome Measures
Name Time Method Differences of peptide specific CTL response in vitro among sequence of peptide vaccine administration 3 months Objective response rate 1 year Feasibility 1 year CD8 population 3 months Survival 1 year Change in level of regulatory T cells 3 months
Trial Locations
- Locations (1)
Fukushima Medical University Hospital
🇯🇵Fukushima, Japan