Clinical trial of peptide vaccination with oral chemotherapy following curative resection for stage III colorectal cancer

• Project/Area Number: 15K10153
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: Digestive surgery
• Research Institution: Kindai University
• Principal Investigator: KAWAMURA Junichiro 近畿大学, 医学部, 講師 (90422948)
• Co-Investigator(Kenkyū-buntansha): 杉浦 史哲 近畿大学, 医学部附属病院, 講師 (10580631) ; 奥野 清隆 近畿大学, 医学部, 教授 (30169239)
• Project Period (FY): 2015-04-01 – 2018-03-31
• Project Status: Completed (Fiscal Year 2017)
• Budget Amount: ¥3,900,000 (Direct Cost: ¥3,000,000、Indirect Cost: ¥900,000); Fiscal Year 2017: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000); Fiscal Year 2016: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000); Fiscal Year 2015: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
• Keywords: 大腸癌 / ペプチドワクチン / 術後補助療法 / CTL反応 / 細胞障害性T細胞 / 細胞障害性Tリンパ球 / CTL

Outline of Final Research Achievements

We conducted a phase II clinical trial involving patients with stage III CRC. All enrolled patients whose human leukocyte antigen (HLA)-A status was double-blinded were administered the same regime of a peptide vaccine and UFT/LV chemotherapy. The primary objective of the study was the comparison of relapse-free survival (RFS) in patients with HLA-A*2402 versus those without HLA-A*2402. A total of 46 patients were enrolled in the study. Three-year RFS was not significantly different between HLA-A*2402 matched and unmatched groups. Three-year RFS was significantly better in patients with positive CTL responses in the HLA-A*2402 matched group compared with those without. In conclusion, vaccination-induced immune responses combined with UFT/LV are positively associated with survival benefit in patients with HLA-A* 2402-positive stage III CRC.

Research Products

• [Journal Article] Multicenter, phase II clinical trial of peptide vaccination with oral chemotherapy following curative resection for stage III colorectal cancer. (2018)
  • Author(s): Kawamura J, Sugiura F, Sukegawa Y,Yoshioka Y, Hida JI, Hazama S, Okuno K.
  • Journal Title: Oncol Lett. Volume: 15 Pages: 4241-4247
  • DOI: 10.3892/ol.2018.7905
  • Peer Reviewed / Open Access / Int'l Joint Research
• [Journal Article] Cytotoxic T lymphocyte response to peptide vaccination predicts survival in stage III colorectal cancer. (2018)
  • Author(s): Kawamura J, Sugiura F, Sukegawa Y,Yoshioka Y, Hida JI, Hazama S, Okuno K.
  • Journal Title: Cancer Sci. Volume: 印刷中 Issue: 5 Pages: 1545-1551
  • DOI: 10.1111/cas.13547
  • Peer Reviewed / Open Access / Int'l Joint Research
• [Journal Article] MicroRNA-6826 and -6875 in plasma are valuable non invasive biomarkers that predict the efficacy of vaccine treatment against metastatic colorectal cancer. (2017)
  • Author(s): Kijima T, Hazama S, Tsunedomi R, Tanaka H, Takenouchi H, Kanekiyo S, Inoue Y, Nakashima M, Iida M, Sakamoto K, Suzuki N, Takeda S, Ueno T, Yamamoto S, Yoshino S, Okuno K, Nagano H.
  • Journal Title: Oncology Reports Volume: 37 Issue: 1 Pages: 23-30
  • DOI: 10.3892/or.2016.5267
  • Peer Reviewed / Open Access / Int'l Joint Research / Acknowledgement Compliant
• [Journal Article] 大腸癌のペプチドワクチン療法 (2015)
  • Author(s): 奥野清隆、杉浦史哲
  • Journal Title: 日本臨床 Volume: 73 Pages: 579-85
• [Presentation] StageIII大腸癌に対する術後補助ペプチドワクチン療法における細胞障害性T細胞(CVTL)反応の臨床的意義 (2018)
  • Author(s): 川村純一郎，杉浦史哲、助川寧，吉岡康多，肥田仁一，硲彰一，奥野清隆
  • Organizer: 第39回癌免疫外科研究会
• [Presentation] StageIII大腸癌根治術後患者に対するUFT/LV併用ペプチドワクチン療法-多施設共同第2相臨床試験ー (2017)
  • Author(s): 川村純一郎，杉浦史哲、助川寧，吉岡康多，肥田仁一，硲彰一，奥野清隆
  • Organizer: 第30回日本バイオセラピー学会学術集会総会
• [Presentation] StageIII大腸癌根治術後患者に対するUFT/LV併用ペプチドワクチン療法の臨床的有効性と安全性の検討-多施設共同第2相臨床試験ー (2017)
  • Author(s): 川村純一郎，杉浦史哲、助川寧，吉岡康多，肥田仁一，硲彰一，奥野清隆
  • Organizer: 第38回癌免疫外科研究会
• [Presentation] StageIII大腸癌根治術後患者に対するUFT/LV併用ペプチドワクチン療法の臨床的有効性と安全性の検討 (2016)
  • Author(s): 川村純一郎、杉浦史哲、助川寧、吉岡康多、肥田仁一、硲彰一、奥野清隆
  • Organizer: 第29回日本バイオセラピー学会学術集会
  • Place of Presentation: 久留米シティプラザ（久留米市）
  • Year and Date: 2016-12-01
• [Presentation] 進行再発大腸癌に対する 7 種ペプチドワクチンカクテル療法の免疫応答と臨床効果 (2016)
  • Author(s): 杉浦史哲、川村純一郎、助川寧、吉岡康多、肥田仁一、硲彰一、奥野清隆
  • Organizer: 第29回日本バイオセラピー学会学術集会
  • Place of Presentation: 久留米シティプラザ（久留米市）
• [Presentation] 進行再発大腸癌に対する7種ペプチドワクチン療法の予後予測因子 (2015)
  • Author(s): 杉浦史哲、吉岡康多、川村純一郎、肥田仁一、奥野清隆
  • Organizer: 第28回日本バイオセラピィ学会学術集会
  • Place of Presentation: 川越東武ホテル(川越)
  • Year and Date: 2015-12-03
• [Presentation] 治癒切除不能Stage IV大腸癌における予後因子の検討 (2015)
  • Author(s): 所 忠男, 奥野清隆, 肥田仁一, 上田和毅, 川村純一郎,大東弘治, 吉藤竹仁, 杉浦史哲
  • Organizer: 第13回日本消化器外科学会大会（JDDW2015）
  • Place of Presentation: グランドプリンスホテル新高輪(東京)
  • Year and Date: 2015-10-08
• [Presentation] 化学療法不応進行再発大腸癌に対する7種ペプチドワクチンカクテル療法の臨床試験 (2015)
  • Author(s): 杉浦史哲、吉岡康多、小北晃弘、亀井敬子、吉藤竹仁、川村純一郎、上田和毅、所 忠男、肥田仁一、奥野清隆
  • Organizer: 第13回日本臨床腫瘍学会学術集会
  • Place of Presentation: ロイトン札幌(札幌)
  • Year and Date: 2015-07-16
• [Presentation] 7種ペプチドワクチンを用いた進行再発大腸癌に対する2試験の治療成績 (2015)
  • Author(s): 杉浦史哲、小北晃弘、吉岡康多、吉藤竹仁、川村純一郎、上田和毅、所 忠男、肥田仁一、奥野清隆
  • Organizer: 第36回癌免疫外科研究会
  • Place of Presentation: 奄美観光ホテル(奄美)
  • Year and Date: 2015-05-14