NCT01266707Unknown1 期
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
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Toxicities as assessed by NCI-CACAE ver3
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Toxicities as assessed by NCI-CACAE ver3
时间窗: 3 months
次要结局
- Survival(1 year)
- 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)
- Change in level of regulatory T cells(3 months)
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
1 期
Antiangiogenic Peptide Vaccine Therapy With Gemcitabine in Treating Patient With Pancreatic CancerPancreatic CancerNCT00639925Fukushima Medical University5
已完成
1 期
Antiangiogenic Peptide Vaccine Therapy With Gemcitabine in Treating Patient With Pancreatic Cancer (Phase1/2)Pancreatic CancerNCT00655785Fukushima Medical University17
Unknown
1 期
HLA-A*0201 Restricted Peptide Vaccine Therapy With Gemcitabine With Gemcitabine in Patient Pancreatic Cancer (Phase1)Pancreatic CancerNCT01266720Fukushima Medical University6
已完成
1 期
Histocompatibility Leukocyte Antigen (HLA)-A*2402 Restricted Peptide Vaccine Therapy in Patients With Gastric CancerGastric CancerNCT00681577Tokyo University14
终止
1 期
Histocompatibility Leukocyte Antigen (HLA)-A*2402 Restricted Peptide Vaccine Therapy in Patients With Colorectal CancerRectal CancerColorectal CancerColon CancerNCT00677287Tokyo University14