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A randomized phase II trial of personalized peptide vaccine with low dose cyclophoshamide in biliary tract cancer

Research Project

Project/Area Number 26430175
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Research Field Tumor therapeutics
Research InstitutionKurume University

Principal Investigator

YUTANI SHIGERU  久留米大学, がんワクチンセンター, 教授 (20279160)

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)
Project Period (FY) 2014-04-01 – 2017-03-31
Project Status Completed (Fiscal Year 2016)
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)
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
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.

Report

(4 results)
  • 2016 Annual Research Report   Final Research Report ( PDF )
  • 2015 Research-status Report
  • 2014 Research-status Report
  • Research Products

    (1 results)

All 2017

All Journal Article (1 results) (of which Peer Reviewed: 1 results,  Open Access: 1 results,  Acknowledgement Compliant: 1 results)

  • [Journal Article] A randomized phase Ⅱ trial of personalized peptide vaccine with low dose cyclophoshamide in biliary tract cancer2017

    • Author(s)
      白濱貴久、由谷 茂、七條茂樹他
    • Journal Title

      Cancer Science

      Volume: in press

    • Related Report
      2016 Annual Research Report
    • Peer Reviewed / Open Access / Acknowledgement Compliant

URL: 

Published: 2014-04-04   Modified: 2018-03-22  

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