Hirata, Kenro

写真a

Affiliation

School of Medicine, Department of Internal Medicine (Gastroenterology and Hepatology) (Shinanomachi)

Position

Senior Assistant Professor (Non-tenured)/Assistant Professor (Non-tenured)

Academic Background 【 Display / hide

  • 2001.04
    -
    2007.03

    Keio University, 医学部

    University

  • 2009.04
    -
    2013.03

    Keio University, 医学研究科

    Graduate School, Doctoral course

Academic Degrees 【 Display / hide

  • 博士(医学), Keio University, Coursework, 2014.02

Licenses and Qualifications 【 Display / hide

  • Fellow of the Japanese Society of Internal Medicine, 2019

  • Diplomate, Subspecialty Board of Medical Oncology, JSMO

  • 日本がん治療認定医機構 がん治療認定医

  • 日本ヘリコバクター学会 H. pylori感染症認定医

  • 日本肝臓学会 肝臓専門医

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Research Areas 【 Display / hide

  • Life Science / Gastroenterology

Research Keywords 【 Display / hide

  • 消化器系悪性腫瘍

  • 胃癌

  • 食道癌

 

Papers 【 Display / hide

  • Prospective feasibility study of indigo naturalis ointment for chemotherapy-induced oral mucositis

    Hirata, K., Yamada, Y., Hamamoto, Y., Tsunoda, K., Muramatsu, H., Horie, S., Sukawa, Y., Naganuma, M., Nakagawa, T. and Kanai, T.

    BMJ Support Palliat Care  2021.10

    ISSN  2045-435x

     View Summary

    OBJECTIVES: Indigo naturalis, a herbal medicine effective against ulcerative colitis, exhibits anti-inflammatory effects and induces interleukin-22-mediated antimicrobial peptide production. Anti-inflammatory activity and the prevention of secondary infection are essential for the management of chemotherapy-induced oral mucositis (CIOM); therefore, we developed an indigo naturalis ointment to be administered topically for CIOM and evaluated its feasibility. METHODS: We performed a single-centre, open-label, prospective feasibility study from March 2017 to December 2018. The key eligibility criteria for the subjects were as follows: (1) receiving chemotherapy for a malignant tumour; (2) grade 1 or 2 CIOM and (3) receiving continuous oral care. The treatment protocol comprised topical indigo naturalis ointment application three times a day for 7 days. The primary endpoint assessed was feasibility. The secondary endpoints assessed were the changes in oral findings, oral cavity pain and safety. RESULTS: Nineteen patients with CIOM were enrolled. The average feasibility (the proportion of prescribed applications that were carried out) observed in this study was 94.7%±8.9% (95% CI 90.5% to 99.0%), which was higher than the expected feasibility. The revised oral assessment guide scores of the mucous membrane domain and total scores were significantly improved. All patients reported a reduction in oral cavity pain, with a median pain resolution duration of 6 days. No serious adverse events were observed. CONCLUSIONS: The indigo naturalis ointment was feasible, and showed the potential for efficacy and safety. Larger randomised controlled trials are needed to further assess the efficacy and safety of indigo naturalis compared with a placebo. TRIAL REGISTRATION NUMBER: UMIN000024271.

  • Analysis of risk factors for immune-related adverse events in various solid tumors using real-world data

    Shimozaki K., Sukawa Y., Sato Y., Horie S., Chida A., Tsugaru K., Togasaki K., Kawasaki K., Hirata K., Hayashi H., Hamamoto Y., Kanai T.

    Future Oncology (Future Oncology)  17 ( 20 ) 2593 - 2603 2021.07

    ISSN  14796694

     View Summary

    The aim of this study was to determine the risk factors for immune-related adverse events (irAEs) induced by immune checkpoint inhibitors. The authors conducted a retrospective study in which patients with malignant melanoma, non-small-cell lung cancer, gastric cancer or renal cell carcinoma who received anti-PD-1/PD-L1 antibodies were included. Of 247 patients, 118 developed a total of 182 irAEs. In the multivariate Fine-Gray regression analysis, serum albumin level ≥3.6 g/dl (hazard ratio: 1.62; 95% CI: 1.10-2.39; p = 0.015) and history of Type I hypersensitivity reactions (hazard ratio: 1.48; 95% CI: 1.02-2.14; p = 0.037) were significantly associated with the development of irAEs. High serum albumin levels and history of Type I hypersensitivity reactions are risk factors for irAEs.

  • Clinical, Endoscopic, and Pathological Characteristics of Immune Checkpoint Inhibitor-Induced Gastroenterocolitis

    Hayashi Y., Hosoe N., Takabayashi K., Limpias Kamiya K.J.L., Tsugaru K., Shimozaki K., Hirata K., Fukuhara K., Fukuhara S., Mutaguchi M., Sujino T., Sukawa Y., Hamamoto Y., Naganuma M., Takaishi H., Shimoda M., Ogata H., Kanai T.

    Digestive Diseases and Sciences (Digestive Diseases and Sciences)  66 ( 6 ) 2129 - 2134 2021.06

    ISSN  01632116

  • The entire intestinal tract surveillance using capsule endoscopy after immune checkpoint inhibitor administration: A prospective observational study

    Shimozaki K., Hirata K., Horie S., Chida A., Tsugaru K., Hayashi Y., Kawasaki K., Miyanaga R., Hayashi H., Mizuno R., Funakoshi T., Hosoe N., Hamamoto Y., Kanai T.

    Diagnostics (Diagnostics)  11 ( 3 )  2021.03

     View Summary

    Background: Despite the proven efficacy of immune checkpoint inhibitors (ICIs) against various types of malignancies, they have been found to induce immune-related adverse events, such as enterocolitis; however, the clinical features of ICI-induced enterocolitis remain to be sufficiently elucidated, which is significant, considering the importance of early detection in the appropriate management and treatment of ICI-induced enterocolitis. Therefore, the current study aimed to determine the utility of capsule endoscopy as a screening tool for ICI-induced enterocolitis. Methods: This single-center, prospective, observational study was conducted on patients with malignancy who received any ICI between April 2016 and July 2020 at Keio University Hospital. Next, second-generation capsule endoscopy (CCE-2) was performed on day 60 after ICI initiation to explore the entire gastrointestinal tract. Results: Among the 30 patients enrolled herein, 23 underwent CCE-2. Accordingly, a total of 23 findings were observed in 14 (60.8%) patients at any portion of the gastrointestinal tract (7 patients in the colon, 4 patients in the small intestine, 2 patients in both the colon and the small intestine, and 1 patient in the stomach). After capsule endoscopy, 2 patients (8.7%) developed ICI-induced enterocolitis: both had significantly higher Capsule Scoring of Ulcerative Colitis than those who had not developed ICI-induced enterocolitis (p = 0.0455). No adverse events related to CCE-2 were observed. Conclusions: CCE-2 might be a safe and useful entire intestinal tract screening method for the early detection of ICI-induced enterocolitis in patients with malignancies.

  • An investigator-initiated phase 2 study of nivolumab plus low-dose ipilimumab as first-line therapy for microsatellite instability—high advanced gastric or esophagogastric junction cancer (No limit, wjog13320g/ca209-7w7)

    Kawakami H., Hironaka S., Esaki T., Chayama K., Tsuda M., Sugimoto N., Kadowaki S., Makiyama A., Machida N., Hirano H., Hirata K., Hara H., Yabusaki H., Komatsu Y., Muro K.

    Cancers (Cancers)  13 ( 4 ) 1 - 12 2021.02

     View Summary

    Nivolumab (NIVO) plus low-dose ipilimumab (IPI) has shown a promising survival benefit in first-line treatment of microsatellite instability-high (MSI-H) colorectal cancer. We hypothesized that this regimen might also be beneficial for MSI-H gastric cancer (GC), which accounts for ~5% of all GC cases. NO LIMIT (WJOG13320G/CA209-7W7) is an investigator-initiated, single-arm, open-label, 14-center phase 2 trial of NIVO plus low-dose IPI for MSI-H GC in the first-line setting. Eligibility criteria include unresectable advanced, recurrent, or metastatic gastric or esophagogastric junction cancer with a histologically confirmed diagnosis of adenocarcinoma; confirmed MSI-H status with the MSI-IVD Kit (FALCO); no prior systemic anticancer therapy; an Eastern Cooperative Oncology Group performance status of 0 or 1; and a measurable lesion per RECIST 1.1. The primary objective of the study is to determine the overall response rate (ORR) for the NIVO+IPI regimen as assessed by blinded independent central review. Secondary end points include progression-free survival, overall survival, duration of response, safety, tolerability, and biomarkers. The number of patients was set at 28 on the basis of the threshold and expected ORR values of 35 and 65%, respectively, with a one-sided alpha error of 0.025 and power of 0.80. Subjects will receive treatment with nivolumab (240 mg) biweekly in combination with ipilimumab (1 mg/kg) every 6 weeks. The results of this study should clarify the therapeutic potential of NIVO+IPI for MSI-H GC in the first-line setting.

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Papers, etc., Registered in KOARA 【 Display / hide

Presentations 【 Display / hide

  • Vulnerable臨床病期IB-III食道扁平上皮癌患者に対するパクリタキセル併用放射線療法の第I相試験

    2021.09

    Oral presentation (general)

  • Randomized phase II trial of weekly paclitaxel + ramucirumab versus weekly nab-paclitaxel + ramucirumab for unresectable advanced or recurrent gastric cancer with peritoneal dissemination refractory to first-line therapy: WJOG10617G/P-SELECT.

    Kenro Hirata, Yasuo Hamamoto, Kenji Tsuchihashi, Chihiro Kondoh, Kentaro Yamazaki, Shuichi Hironaka, Masahiko Ando, Chiyo K Imamura, Kenichi Yoshimura, Kei Muro

    The European Society for Medical Oncology Cancer Congress 2019, 

    2019.09

    Poster presentation

  • 咽頭メラノーシスの視認は上気道消化管新生物予測に有用である

    Kenro Hirata

    第15回日本臨床腫瘍学会学術集会, 

    2017.07

  • Soft palatal melanosis as a predictor for neoplasia in the upper aerodigestive tract.

    Kenro Hirata

    American Society of Clinical Oncology 2017, 

    2017.06

  • 上気道消化管新生物予測における咽頭メラノーシスの有用性の検討

    Kenro Hirata

    アルコール医学生物学研究会, 

    2017.01

    Oral presentation (general)

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Research Projects of Competitive Funds, etc. 【 Display / hide

  • がん化学療法後に増悪した根治切除不能な進行・再発食道扁平上皮癌に対するNivolumab療法におけるバイオマーカー探索を含む前向き観察研究

    2021
    -
    Present

    Joint research, Principal investigator

  • 化学療法誘発性口腔粘膜炎における青黛軟膏の臨床開発

    2021
    -
    Present

    Joint research, Principal investigator

  • Vulnerable高齢食道扁平上皮癌患者に対する標準治療の確立

    2020.04
    -
    2023.03

    Research grant, Principal investigator

  • BRAF変異型Stage IV大腸癌に対するFOLFOXIRI+BEV療法の有効性に関する後方視的検討

    2020.04
    -
    2021.03

    Other, Principal investigator

  • オンライン診療を用いた緩和ケアの有用性に関する検討

    2020.04
    -
    2021.03

    Joint research, Principal investigator

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Awards 【 Display / hide

  • 有吉・福岡賞

    2021.06, 西日本がん研究機構(West Japan Oncology Group: WJOG)

    Type of Award: Award from publisher, newspaper, foundation, etc.

  • J-HOPE award

    2019.03, The University of Texas MD Anderson Cancer Center

    Type of Award: Award from publisher, newspaper, foundation, etc.

  • 内科学教室同窓会 松木康夫賞

    2018.06

  • 第8回 ICAT publication award

    2013.12

  • 第7回 ICAT award 最優秀賞

    2012.12

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Courses Taught 【 Display / hide

  • 医学概論

    2021, Spring Semester, Lecture, Within own faculty

  • 医学概論

    2020, Spring Semester, Lecture, Within own faculty

  • 医学概論

    2019, Spring Semester, Lecture, Within own faculty

  • 医学概論

    2018, Spring Semester, Lecture, Within own faculty

 

Social Activities 【 Display / hide

  • がん臨床研究指導者養成プロジェクト「虎の穴」ジュニアチューター

    2021
  • 特定臨床研究への対応の実際

    西日本がん研究機構(WJOG)

    2020.05
  • 大阪オンコロジーセミナー Meeting the Cancer Experts 2020 食道癌

    西日本がん研究機構(WJOG)

    2020.04
  • 特定臨床研究への対応の実際

    西日本がん研究機構(WJOG)

    2019
  • がん臨床研究指導者養成プロジェクト「虎の穴」ジュニアチューター

    2019

Committee Experiences 【 Display / hide

  • 2021
    -
    Present

    西日本がん研究機構(WJOG)消化器グループ 若手会FLAG 副代表, WJOG(西日本がん研究機構)

  • 2019
    -
    Present

    食道癌診療ガイドライン システマティックレビュアー

  • 2019
    -
    Present

    JCOG(日本臨床腫瘍研究グループ)食道がんグループ 医学審査員

  • 2019
    -
    Present

    西日本がん研究機構(WJOG)臓器横断的ワーキンググループ 委員

  • 2019
    -
    Present

    胃癌治療ガイドライン システマティックレビュアー

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