A randomized phase II trial of personalized peptide vaccine with low dose cyclophoshamide in biliary tract cancer
| Project/Area Number |
26430175
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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 |
Tumor therapeutics
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| Research Institution | Kurume University |
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Principal Investigator |
YUTANI SHIGERU 久留米大学, がんワクチンセンター, 教授 (20279160)
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| Co-Investigator(Kenkyū-buntansha) |
白濱 貴久 久留米大学, 医学部, 助教 (00647787)
七條 茂樹 久留米大学, がんワクチンセンター, 准教授 (30080592)
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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 |
¥5,200,000 (Direct Cost: ¥4,000,000、Indirect Cost: ¥1,200,000)
Fiscal Year 2016: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Fiscal Year 2015: ¥1,820,000 (Direct Cost: ¥1,400,000、Indirect Cost: ¥420,000)
Fiscal Year 2014: ¥2,210,000 (Direct Cost: ¥1,700,000、Indirect Cost: ¥510,000)
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| Keywords | 胆道がん / ペプチドワクチン / 免疫療法 / キラーーT細胞 / シクロホスファミド / 血清IL-6値 / Peptide vaccine / Overall survival / PFS / Cyclophoshamide / Billiary tract cancer / CTL / Immunotherapy / T cell exhaustion / Treg / MDSC / Cancer vaccine / Biliary tract cancer / Tcell exhaustion / ELISPOT |
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| Outline of Final Research Achievements |
In the current study, we conducted an open-label randomized phase II study to test whether low dose cyclophosphamide (CPA) could improve antigen-specific immune responses and clinical efficancy of personalized peptide vaccination (PPV) in 49 previously treated aBTC patients. Patients with aBTC were randomiy assigned to receive PPV with low dose CPA (100 mg/day for 7 days before vaccination) (PPV/CPA, n=24) or PPV alone (n=25). T cell responses to the vaccinated peptides in the PPV/CPA arm tested to be greater than those in the PPV alone arm. The PPV/CPA arm showed significantly better overall survival (median time: 12.1 vs 5.9 M; HR: 0.376; P=0.004), compared to the PPV alone arm. The PPV alone arm, but not the PPV/CPA arm, showed significant increase in plasma IL-6 after vaccinations, which might be associated with inhabitation of antigen-specific T cell responses.
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Report
(4 results)
Research Products
(1 results)
