Department of Early Clinical Development



Takako Eguchi Nakajima M.D., Ph.D

This field is a new graduate field of research within the Department of Early Clinical Development, Kyoto Innovation Center for New Generation Clinical Trials and iPS Cell Therapy (Ki-CONNECT), which was inaugurated in April 2020. Education involves designing/conducting translational research necessary to overcome efficiently through the “valley of death” between preclinical studies and early phase clinical trials and the design/conduct of phase 0/1 trials. In clinical practice, by way of teaching techniques of early clinical development, we provide you opportunities to experience early phase clinical trials that recruit patients with cancer/incurable disease who may receive a transplant of iPS cells, and also healthy volunteers.

Research and Education

The field of early clinical development is staffed by medical doctors much experienced in planning and conducting translational research or early phase clinical trials (including investigator-initiated trials). We collaborate not only with researchers at Kyoto University but also with the Institute for Advancement of Clinical and Translational Science (iACT), Kyoto University Medical Science and Business Liaison Organization (KUMBL), Kyoto University Innovation Capital Co., Ltd. (iCAP), etc. to promote successful clinical development and initiation of translational research design/conduct and early phase clinical trial planning and implementation. Through research design and onsite experience, you will become a full-fledged investigator at the forefront of global early clinical development in the future.
In clinical practice, our goal is the complete cure of cancers and incurable diseases. We provide comprehensive medical care for all diseases and individual care for each patient. You will be trained to deal with any unknown adverse events that might happen in first-in-human studies. You may be interested in contributing to the future of medicine by collaborating with patient and healthy participant volunteers in clinical trials of new treatments. Both new graduates and experienced medical doctors are welcome. Experience in clinical/basic research does not matter. You can visit us any time. Please feel free to contact us by email or phone.

Ki-CONNECT Grand opening in Apr 2020


Department of Early Clinical Development


Recent Publications

  1. Nakajima TE, Yamaguchi K, Boku N, Hyodo I, Mizusawa J, Hara H, Nishina T, Sakamoto T, Shitara K, Shinozaki K, Katayama H, Nakamura S, Muro K, Terashima M. Randomized phase II/III study of 5-fluorouracil/l-leucovorin versus 5-fluorouracil/l- leucovorin plus paclitaxel administered to patients with severe peritoneal metastases of gastric cancer (JCOG1108/WJOG7312G). Gastric Cancer(2020), 2020(DOI: https://doi.org/10.1007/s10120-020-01043-x)
  2. Nakajima TE (Corresponding author), Boku N, Doi A, Arai H, Mizukami T, Horie Y, Izawa N,  irakawa M, Ogura T, Tsuda T, Sunakawa Y. Phase I study of the anti-heparin-binding epidermal growth factor-like growth factor antibody U3-1565 with cetuximab in patients with cetuximab- or panitumumab-resistant metastatic colorectal cancer. Investigational New Drugs 38: 410-418, 2020
  3. Yoshiaki Nakamura, Hiroya Taniguchi, Masafumi Ikeda, Hideaki Bando, Ken Kato, Chigusa  Morizane, Taito Esaki, Yoshito Komatsu, Yasuyuki Kawamoto, Naoki Takahashi, Makoto Ueno, Yoshinori Kagawa, Tomohiro Nishina, Takeshi Kato, Yoshiyuki Yamamoto, Junji Furuse, Tadamichi Denda, Hisato Kawakami, Eiji Oki, Takako Nakajima, Naohiro Nishida, Kensei Yamaguchi, Hisateru Yasui, Masahiro Goto , Nobuhisa Matsuhashi, Koushiro Ohtsubo, Kentaro Yamazaki, Akihito Tsuji, Wataru Okamoto, Katsuya Tsuchihara, Takeharu Yamanaka, Izumi Miki, Yasutoshi Sakamoto, Hiroko Ichiki, Masayuki Hata, Riu Yamashita, Atsushi Ohtsu, Justin I. Odegaard and Takayuki Yoshino. Clinical utility of circulating tumor DNA sequencing in advanced gastrointestinal cancer: SCRUM-Japan GI-SCREEN and GOZILA studies. Nature Medicine, 2020 (https://doi.org/10.1038/s41591-020-1063-5)
  4. Yoshihiko Fujita, Masataka Taguri, Kentaro Yamazaki, Junji Tsurutani, Kazuko Sakai, Takahiro Tsushima, Michitaka Nagase, Hiroshi Tamagawa, Shinya Ueda, Takao Tamura, Yasushi Tsuji, Kohei Murata, Koichi Taira, Tadamichi Denda, Toshikazu Moriwaki, Sadao Funai, Takako Eguchi Nakajima, Kei Muro, Akihito Tsuji, Motoki Yoshida, Koichi Suyama, Takuya Kurimoto, Naotoshi Sugimoto, Eishi Baba, Nobuhiko Seki, Mikio Sato, Takaya Shimura, Narikazu Boku, Ichinosuke Hyodo, Takeharu Yamanaka, and Kazuto Nishio. aCGH Analysis of Predictive Biomarkers for Response to Bevacizumab plus Oxaliplatin‐ or Irinotecan‐Based Chemotherapy in Patients with Metastatic Colorectal Cancer.The Oncologist 24(3): 327–337, 2019
  5. Ito Y, Tsuda T, Minatogawa H, Kano S, Sakamaki K, Ando M, Tsugawa K, Kojima Y, Furuya N, Matsuzaki K, Fukuda M, Sugae S, Ohta I, Arioka H, Tokuda Y, Narui K, Tsuboya A, Suda T, Morita S, Boku N, Yamanaka T, Nakajima TE (Corresponding author). Placebo-Controlled, Double-Blinded Phase III Study Comparing Dexamethasone on Day 1 With Dexamethasone on Days 1 to 3 With Combined Neurokinin-1 Receptor Antagonist and Palonosetron in High-Emetogenic Chemotherapy. Journal of Clinical Oncology 36(10): 1000-1006, 2018

Department of Early Clinical Development

Takako Eguchi Nakajima, Professor
Takeshi Sawada, Junior Associate Professor
Masaru Fukahori, Program-Specific Assistant Professor
Masahiko Aoki, Program-Specific Assistant Professor
TEL:075-751-4733
FAX:075-751-4753