| Project/Area Number |
26461965
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Multi-year Fund |
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| Section | 一般 |
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| Research Field |
General surgery
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| Research Institution | Kurume University |
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Principal Investigator |
Toh Uhi 久留米大学, 医学部, 准教授 (60268901)
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| Co-Investigator(Renkei-kenkyūsha) |
ITOH Kyogo 久留米大学, 医学部, 教授 (50125499)
SHICHIJO Shigeki 久留米大学, 医学部, 准教授 (30080592)
YAMADA Akira 久留米大学, 医学部, 教授 (50158177)
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| Project Period (FY) |
2014-04-01 – 2017-03-31
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| Project Status |
Completed (Fiscal Year 2016)
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| Budget Amount *help |
¥4,940,000 (Direct Cost: ¥3,800,000、Indirect Cost: ¥1,140,000)
Fiscal Year 2016: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Fiscal Year 2015: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Fiscal Year 2014: ¥2,470,000 (Direct Cost: ¥1,900,000、Indirect Cost: ¥570,000)
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| Keywords | ペプチドワクチン / トリプルネガティブ乳癌 / 乳がん / トリプルネガティブ乳がん |
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| Outline of Final Research Achievements |
We conducted an early phase II study to evaluate the safety and the efficacy of a new regimen using multiple peptide vaccines (KRM-19) for patients (pts) with metastatic triple negative breast cancer (mTNBC). KRM-19 consisted of 19 mixed peptides were chosen from the previously reported 31 peptide vaccines according to their immunologic effect and safety profile. All pts had histologically confirmed measurable ER-PgR-Her2- mBC. KRM-19 was administrated subcutaneously every week for 6 doses. The chemo-endocrine therapy were not permitted for the combination. The primary endpoint was safety and anti-tumor immunologic effect, and the secondary endpoints were clinical responses and progression free survival (PFS). 11 pts have been enrolled. Measurement of peptide-specific cytotoxic T lymphocyte (CTL) and IgG responses were conducted before and after vaccination. Correlation between PFS and the increased IgG response and/or CTL levels will be investigated. (Registry number: UMIN000014616)
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| Academic Significance and Societal Importance of the Research Achievements |
近年乳がんの治療成績が飛躍的に向上されたが、トリプルネガティブ（ER陰性、PgR陰性、HER2陰性）乳がんは依然治療手段が限られている。様々な抗がん剤や分子標的治療薬が臨床治療に実用されるようになっているが、副作用の少ないがんワクチンが開発された場合は大きな意義を有する。今回、ＨＬＡ型に関わらず投与可能な19種類ペプチドカクテル（KRM-19）を開発し、その臨床投与により安全性と有効性を検証するとともに、乳癌癌局所の組織免疫環境やこれまでワクチン療法を受けた患者の血液サンプルの抗体化などの変化を解析し、臨床的にワクチン療法で有効な患者群を検証し、新しい乳癌の集学的治療法が確立に繋がる。
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