Phase Ⅰ/Ⅱ Trial of Human Leukocyte Antigen (HLA)-A*2402-Restricted Vascular Endothelial Growth Factor Receptor 1 (VEGFR1)-Derived Peptide Vaccination Combined With Gemcitabine for Advanced Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- PhaseⅠ; safety (NCI CTCAE v.3) PhaseⅡ；time to progression (RECIST)
研究概览
简要总结
Feasibility and efficacy of combined modality intervention using chemotherapeutic agent gemcitabine with anti-angiogenic peptide vaccination targeting VRGFR1 should be determined in case of advanced/inoperable or therapy-resistant pancreatic cancer patients.
Gemcitabine 1,000mg/m2 BSA will be administered on day1, day8, day15, day29, day36, day43, respectively.
HLA-A*2402-restricted VEGFR1-derived peptide (VEGFR1-A24-1084; SYGVLLWEI) emulsified with Montanide ISA51 will be subcutaneously injected twice weekly for 8weeks (total 16 doses).
详细描述
HLA-A*2402-restricted cytotoxic T lymphocyte (CTL) clones were obtained from healthy volunteer donor peripheral blood.
These CTL clones showed potent cytotoxicities selectively against VEGFR1-expressing target cells in HLA-class I-restricted manner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* Heterozygote or homozygote of HLA-A\*2402 allele
- •* Inoperable or recurrent pancreatic cancer with or without any prior therapy
- •* Difficult to continue the prior therapy due to treatment-related toxicities
- •* ECOG performance status 0-2
- •* Evaluable primary or metastatic lesion with RECIST criteria
- •* Clearance period from prior therapy more than 4 weeks
- •* Life expectancy more than 3 months
- •* Laboratory values as follows 2,000/μL\100,000/μL AST\<150IU/L ALT\<150IU/L Total bilirubin\<3.0mg/dl Serum creatinine\<3.0mg/dl
排除标准
- •Pregnancy (refusal or inability to use effective contraceptives)
- •Breastfeeding
- •Active or uncontrolled infection
- •Systemic use of corticosteroids or immunosuppressants
- •Uncontrollable brain metastasis and/or meningeal infiltration
- •Unhealed external wound
- •Possibilities of complicated paralytic ileus or interstitial pneumonitis
- •Decision of not eligible determined by principal investigator or attending doctor
结局指标
主要结局
PhaseⅠ; safety (NCI CTCAE v.3) PhaseⅡ；time to progression (RECIST)
时间窗: 1 year
次要结局
- Immune response (ELISPOT, Perforin/FoxP3 FACS, in vitro CTL assay etc.)(1 year)
- Tumor regression(Imaging study, tumor marker, etc.)(1 year)