Annual Report 2024
Clinical Research Support Office
- Clinical Research Planning Division
- Clinical Research Management Division
- Seeds Development Promotion Division
- Clinical Research Coordinating Division (Clinical Research Coordinating Section, Clinical Trial Administration Section, Clinical Study Support Section)
Yasutoshi Kuboki, Masafumi Ikeda, Kiyotaka Yoh, Yoichi Naito, Tomohiro Kadota, Yuichiro Tsukada, Junichiro Yuda, Yukie Kimura, Takahiro Sakai, Keiko Abe, Mariko Ishizuka, Yoshimi Izumi, Chiyo Ito, Yuko Ito, Hasumi Okayasu, Hiromi Kawamura, Sumino Kimijima, Masumi Kudo, Reiko Sugaya, Nanako Takakuwa, Sayuri Nochi, Noriko Hatayama, Miyuki Hara, Hiromi Motoyanagi, Chiharu Hirano, Saori Yokoba, Yoko Takada, Aya Iwamoto, Misato Makiishi, Kiyoko Adachi, Koko Komata, Keiko Yamamoto, Rie Taniguchi, Yasuko Yoshihara, Kazumi Yamaguchi, Tomoko Suzuki, Atsuko Katagiri, Maki Umezawa, Tomomi Kugio, Naoya Kobayashi, Yuki Suzuki, Tomoko Matsumura, Yukiyo Asano, Tamae Yabuki, Kayo Okawara, Ai Yokokawa, Mai Yamao, Tomoko Watanabe, Ayako Arai, Miwa Chishiki, Hiroko Nakanishi, Mayumi Nagino, Naoya Asao, Natsuko Takagi, Noriko Noda, Aki Hashimoto, Hikari Matsuki, Masahiko Ozaki, Tomoka Okano, Kazunori Masai, Mai Hashimoto, Hiromi Suto, Satomi Tago, Akiko Yumura, Ayako kimura, Yuriko Eguchi, Mariko Kamata, Akiko Shimada, Chiaki Koizumi, Takashi Kojima, Sakie Takasu, Rina Nitta, Anna Ozawa, Chikoto Okano, Hiromi Kojima, Hisako Nakanishi, Yuka Yamaguchi, Yuko Arano
Introduction
The Clinical Research Support Office supports the clinical trial program conducted in the National Cancer Center Hospital East (NCCHE).
The Clinical Research Coordinating Division works to achieve the development and early approval of innovative new drugs and medical devices across all fields, including pharmaceuticals, medical devices, regenerative medicine products such as cell therapy and virus therapy, and new modalities such as photoimmunotherapy and radioligand therapy. This is accomplished through the swift review of clinical trials and clinical research and support for safe research implementation. Furthermore, it deepens collaboration with clinical trial-related departments to promote the establishment of our hospital's Quality Management System (QMS) and a quality assurance framework compliant with ISO 9001. Going forward, it will develop a flexible system capable of adapting to the rapid advancement of IoT and the accompanying changes in the clinical trial environment (Decentralized Trials / Virtual Trials).
The Team and What We Do
- Clinical Research Planning Division
- Clinical Research Management Division
Through the clinical datacenter, study management, site visit monitoring, safety information, and medical writing.
- Seeds Development Promotion Division
Promote seeds development though program management and start-up support.
- Clinical Research Coordinating Division
Research Activities
In the FY2024 Chiken-Ecosystem Project implemented by the PMDA, the National Cancer Center was selected as one of the project implementing organizations. To eliminate drug lag and loss in Japan, we conducted surveys and exchanged opinions with approximately 20 medical institutions regarding challenges to be addressed in conducting clinical trials more efficiently and increasing the number of trials. As a project outcome, we compiled the challenges and their solutions.
Clinical Trials
We supported 3 new clinical investigator-initiated clinical trials as ARO in 2024
Education
Newly hired staff underwent tailored education programs aligned with their roles, such as clinical research coordinators or clinical trial office staff. Progress was regularly assessed and evaluated throughout the training. Additionally, the NCCHE accepted rotators from clinical trial-related departments according to its unique job rotation system and provided training.
Future Prospects
Moving forward, we will continue to conduct safe, high-quality trials across all phases-from early to late-stage-for pharmaceuticals, medical devices, and regenerative medicine products, including those involving new modalities. Furthermore, we will contribute not only to cancer treatment development but also to improving Japan's clinical trial environment. This includes addressing significant regulatory changes such as compliance with ICH-E6(R3), and introducing benchmark-based cost calculation methods like single IRB and FMV, which are common overseas. We will strive to eliminate drug lag and drug loss.
Table 1. Status of Clinical Trials and Other Activities
Table 2. Status of New Clinical Trials, etc.
Table 3. FIH/FIJ Clinical Trial Subject Count
List of papers published in 2024
Journal
1. Bando H, Kumagai S, Kotani D, Mishima S, Irie T, Itahashi K, Tanaka Y, Habu T, Fukaya S, Kondo M, Tsushima T, Hara H, Kadowaki S, Kato K, Chin K, Yamaguchi K, Kageyama SI, Hojo H, Nakamura M, Tachibana H, Wakabayashi M, Fukui M, Fuse N, Koyama S, Mano H, Nishikawa H, Shitara K, Yoshino T, Kojima T. Atezolizumab following definitive chemoradiotherapy in patients with unresectable locally advanced esophageal squamous cell carcinoma - a multicenter phase 2 trial (EPOC1802). Nature cancer, 6:445-459, 2025
2. Sasaki T, Kuno H, Nomura K, Muramatsu Y, Aokage K, Samejima J, Taki T, Goto E, Wakabayashi M, Furuya H, Taguchi H, Kobayashi T. CZT-based photon-counting-detector CT with deep-learning reconstruction: image quality and diagnostic confidence for lung tumor assessment. Japanese journal of radiology, 2025
3. Yagisawa M, Taniguchi H, Satoh T, Kadowaki S, Sunakawa Y, Nishina T, Komatsu Y, Esaki T, Sakai D, Doi A, Kajiwara T, Ono H, Asano M, Hirano N, Odegaard J, Fujii S, Nomura S, Bando H, Sato A, Yoshino T, Nakamura Y. Trastuzumab Deruxtecan in Advanced Solid Tumors With Human Epidermal Growth Factor Receptor 2 Amplification Identified by Plasma Cell-Free DNA Testing: A Multicenter, Single-Arm, Phase II Basket Trial. Journal of clinical oncology, 42:3817-3825, 2024
4. Aokage K, Koyama S, Kumagai S, Nomura K, Shimada Y, Yoh K, Wakabayashi M, Fukutani M, Furuya H, Miyoshi T, Tane K, Samejima J, Taki T, Hayashi T, Matsubayashi J, Ishii G, Nishikawa H, Ikeda N, Tsuboi M. Efficacy, Safety, and Influence on the Tumor Microenvironment of Neoadjuvant Pembrolizumab plus Ramucirumab for PD-L1-Positive NSCLC: A Phase II Trial (EAST ENERGY). Clinical cancer research, 30:5584-5592, 2024