よむ、つかう、まなぶ。
資料１－３ 指摘事項に対する回答 (17 ページ)
出典
| 公開元URL | https://www.mhlw.go.jp/stf/newpage_35961.html |
| 出典情報 | 先進医療会議 先進医療技術審査部会（第155回 11／9）《厚生労働省》 |
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て、参加しています。また、本臨床研究は化学療法部と共に連携し進めます。化学療法部の安藤
は医師主導治験「NRG1 融合遺伝子を有する進行固形癌患者に対するアファチニブマレイン酸塩
（BIBW2992）のバスケット試験（jRCT2041220036）
」を治験調整医師として、実施しております。
研究責任医師及び研究分担医師の臨床研究による成果を以下のようにまとめました。
・ Yamaguchi J, Yokoyama Y, Fujii T, Yamada S, Takami H, Kawashima H, Ohno E, Ishikawa T, Maeda
O, Ogawa H, Kodera Y, Nagino M, Ebata T. Results of a Phase II Study on the Use of Neoadjuvant
Chemotherapy (FOLFIRINOX or GEM/nab-PTX) for Borderline-resectable Pancreatic Cancer (NUPAT01). Ann Surg. 275(6): 1043-1049, 2022
・ Morita S, Minami H, Mitsuma A, Toyoda M, Kiyota N, Ando Y. A phase I study of LCL161, a novel oral
pan-inhibitor of apoptosis protein (IAP) antagonist, in Japanese patients with advanced solid tumors. Asia
Pac J Clin Oncol. 18(5): e427-e434, 2022
・ Mizutani Y, Iida T, Ohno E, Ishikawa T, Kinoshita F, Kuwatsuka Y, Imai M, Shimizu S, Tsuruta T,
Enomoto S, Kawashima H, Fujishiro M. Safety and efficacy of MIKE-1 in patients with advanced
pancreatic cancer: a study protocol for an open-label phase I/II investigator-initiated clinical trial based
on a drug repositioning approach that reprograms the tumour stroma. BMC Cancer. 22(1): 205, 2022.
・ Maeda O, Matsuoka A, Yanagawa M, Muroyama Y, Watanabe K, Liang Y, Ishikawa T, Ohno E,
Kawashima H, Umegaki H, Kuzuya M, Ando Y. Selection of chemotherapy for older patients with
pancreatic cancer based on geriatric assessment. J Geriatr Oncol. 13(8): 1260-1263, 2022
・ Maeda O, Fukaya M, Koike M, Miyata K, Kanda M, Nishida K, Ando M, Kodera Y, Ando Y.
Preoperative docetaxel, cisplatin, and fluorouracil treatment with pegfilgrastim on day 7 for patients with
esophageal cancer: A phase II study. Asia Pac J Clin Oncol. 18(6): 578-585, 2022
・ Yamada K, Sawada T, Nakamura M, Yamamura T, Maeda K, Ishikawa E, Iida T, Mizutani Y, Kakushima
N, Ishikawa T, Furukawa K, Ohno E, Honda T, Kawashima H, Ishigami M, Furune S, Hase T, Yokota
K, Maeda O, Hashimoto N, Akiyama M, Ando Y, Fujishiro M. Clinical characteristics of gastrointestinal
immune-related adverse events of immune checkpoint inhibitors and their association with survival.
World J Gastroenterol. 27(41): 7190-7206, 2021
・ Schöffski P, Concin N, Suarez C, Subbiah V, Ando Y, Ruan S, Wagner JP, Mansfield K, Zhu X, Origuchi
S, DiDominick S, Bialucha CU, Faris JE, Tran B. A Phase 1 Study of a CDH6-Targeting Antibody-Drug
Conjugate in Patients with Advanced Solid Tumors with Evaluation of Inflammatory and Neurological
Adverse Events. Oncol Res Treat. 44(10): 547-556, 2021
・ Minami H, Doi T, Toyoda M, Imamura Y, Kiyota N, Mitsuma A, Shimokata T, Naito Y, Matsubara N,
Tajima T, Tokushige K, Ishihara K, Cameron S, Ando Y. Phase I study of the antiprogrammed cell death1 Ab spartalizumab (PDR001) in Japanese patients with advanced malignancies. Cancer Sci. 112(2): 725733, 2021
・ Wick A, Bähr O, Schuler M, Rohrberg K, Chawla SP, Janku F, Schiff D, Heinemann V, Narita Y, Lenz
HJ, Ikeda M, Ando Y, Wick W, Steinbach JP, Burger MC, Wenger K, Lassen U, Sankhala KK, Roggia
C, Genvresse I, Munhoz C, Rentzsch C, Reschke S, Langer S, Wagner M, Kaulfuss S, Cai C, Lagkadinou
E, Jeffers M, Peña C, Tabatabai G. Phase I Assessment of Safety and Therapeutic Activity of
6
は医師主導治験「NRG1 融合遺伝子を有する進行固形癌患者に対するアファチニブマレイン酸塩
（BIBW2992）のバスケット試験（jRCT2041220036）
」を治験調整医師として、実施しております。
研究責任医師及び研究分担医師の臨床研究による成果を以下のようにまとめました。
・ Yamaguchi J, Yokoyama Y, Fujii T, Yamada S, Takami H, Kawashima H, Ohno E, Ishikawa T, Maeda
O, Ogawa H, Kodera Y, Nagino M, Ebata T. Results of a Phase II Study on the Use of Neoadjuvant
Chemotherapy (FOLFIRINOX or GEM/nab-PTX) for Borderline-resectable Pancreatic Cancer (NUPAT01). Ann Surg. 275(6): 1043-1049, 2022
・ Morita S, Minami H, Mitsuma A, Toyoda M, Kiyota N, Ando Y. A phase I study of LCL161, a novel oral
pan-inhibitor of apoptosis protein (IAP) antagonist, in Japanese patients with advanced solid tumors. Asia
Pac J Clin Oncol. 18(5): e427-e434, 2022
・ Mizutani Y, Iida T, Ohno E, Ishikawa T, Kinoshita F, Kuwatsuka Y, Imai M, Shimizu S, Tsuruta T,
Enomoto S, Kawashima H, Fujishiro M. Safety and efficacy of MIKE-1 in patients with advanced
pancreatic cancer: a study protocol for an open-label phase I/II investigator-initiated clinical trial based
on a drug repositioning approach that reprograms the tumour stroma. BMC Cancer. 22(1): 205, 2022.
・ Maeda O, Matsuoka A, Yanagawa M, Muroyama Y, Watanabe K, Liang Y, Ishikawa T, Ohno E,
Kawashima H, Umegaki H, Kuzuya M, Ando Y. Selection of chemotherapy for older patients with
pancreatic cancer based on geriatric assessment. J Geriatr Oncol. 13(8): 1260-1263, 2022
・ Maeda O, Fukaya M, Koike M, Miyata K, Kanda M, Nishida K, Ando M, Kodera Y, Ando Y.
Preoperative docetaxel, cisplatin, and fluorouracil treatment with pegfilgrastim on day 7 for patients with
esophageal cancer: A phase II study. Asia Pac J Clin Oncol. 18(6): 578-585, 2022
・ Yamada K, Sawada T, Nakamura M, Yamamura T, Maeda K, Ishikawa E, Iida T, Mizutani Y, Kakushima
N, Ishikawa T, Furukawa K, Ohno E, Honda T, Kawashima H, Ishigami M, Furune S, Hase T, Yokota
K, Maeda O, Hashimoto N, Akiyama M, Ando Y, Fujishiro M. Clinical characteristics of gastrointestinal
immune-related adverse events of immune checkpoint inhibitors and their association with survival.
World J Gastroenterol. 27(41): 7190-7206, 2021
・ Schöffski P, Concin N, Suarez C, Subbiah V, Ando Y, Ruan S, Wagner JP, Mansfield K, Zhu X, Origuchi
S, DiDominick S, Bialucha CU, Faris JE, Tran B. A Phase 1 Study of a CDH6-Targeting Antibody-Drug
Conjugate in Patients with Advanced Solid Tumors with Evaluation of Inflammatory and Neurological
Adverse Events. Oncol Res Treat. 44(10): 547-556, 2021
・ Minami H, Doi T, Toyoda M, Imamura Y, Kiyota N, Mitsuma A, Shimokata T, Naito Y, Matsubara N,
Tajima T, Tokushige K, Ishihara K, Cameron S, Ando Y. Phase I study of the antiprogrammed cell death1 Ab spartalizumab (PDR001) in Japanese patients with advanced malignancies. Cancer Sci. 112(2): 725733, 2021
・ Wick A, Bähr O, Schuler M, Rohrberg K, Chawla SP, Janku F, Schiff D, Heinemann V, Narita Y, Lenz
HJ, Ikeda M, Ando Y, Wick W, Steinbach JP, Burger MC, Wenger K, Lassen U, Sankhala KK, Roggia
C, Genvresse I, Munhoz C, Rentzsch C, Reschke S, Langer S, Wagner M, Kaulfuss S, Cai C, Lagkadinou
E, Jeffers M, Peña C, Tabatabai G. Phase I Assessment of Safety and Therapeutic Activity of
6