Annual Report 2024

Department of Clinical Development Promotion

Shigehiro Yagishita, Tomomi Yoshino, Makoto Ohno, Gou Okumura, Kazuki Yokoyama, Chikashi Watase, Yuki Kojima, Yuki Shinno, Hiroyuki Daiko, Daisuke Kurita, Konosuke Moritani, Naoya Toyoshima, Yasuhiko Mizuguchi, Ayumu Matsuda, Yasuhito Tanase, Suguru Fukushima, Dai Ogata, Suguru Fukuhara, Takashi Tanaka, Hiroto Ishiki, Yuko Yanai, Kae Okuma, Takeshi Iwasa, Takao Ueno, Hirotaka Matsui, Takafumi Koyama, Jun Sato, Yuki Katsuya, Mao Okada, Hiroki Nakayama, Reiko Makihara, Ikumi Iida, Kaori Shimada, Masataka Ueda, Tomoko Watanabe, Manami Matsukawa, Shun Yamamoto, Yukihiro Yoshida, Tatsuya Yoshida, Tsutomu Hayashi, Hidekazu Hirano, Seiichiro Abe, Hiroyuki Takamaru, Takeshi Takamoto, Daisuke Ban, Shuhei Osaki, Ryoichi Sadahiro, Ayumu Arakawa, Eriko Satomi, Hiromichi Matsuoka, Shunsuke Sugawara, Chihiro Ito, Shintaro Kimura, Kuniko Sunami, Hiroki Kakishima, Satoyo Oda, Ami Takano, Yuya Kanai, Hiromi Suzuki, Yutaka Saito, Yuji Matsumoto, Yuta Maruki, Takashi Kubo, Chiaki Hayashi, Makoto Hirata, Yoshitaka Honma, Tatsunori Shimoi, Kazuki Sudo, Shunsuke Kondo, Akinobu Hamada, Wataru Munakata, Ken Ohashi, Ken Kato, Hironobu Hashimoto, Kan Yonemori, Noboru Yamamoto

Introduction

 Outline: In order to respond to the diversification of cancer treatment development, it is newly established in April 2023 with the goal of promoting and strengthening drug development, TR research, and medical device development, and it consists of three parts: Division of Drug and Diagnostic Development Promotion, Division of Translational Research Promotion, and Division of Medical Device Innovation Promotion. The missions of each division are as follows:

 Division of Drug and Diagnostic Development Promotion: Planning and progress management of cross-organ-sectional research and clinical research conducted at the National Cancer Center Hospital, which mainly consists of members of medical departments and pharmacy departments, aims to conduct research/trials smoothly. It also serves as a window for the National Cancer Center when pharmaceutical companies plan and conduct clinical trials for new drugs across organs, with the goal of conducting rapid trials and involving patients. Developing a system within the hospital to promote clinical trials, such as the construction of a database that can be shared by each department and the sharing of clinical trial information within the hospital. In addition, by enhancing the collaboration among the departments of internal medicine, new trials and research on new ideas will be drafted and conducted without being trapped by each organ and department. In addition, in order to deepen the cooperation between hospitals for the purpose of referring patients to clinical trials, and to improve the literacy of medical personnel regarding clinical trials and clinical research, visits will be made to hospitals with a high number of patient referrals to this hospital, and workshops will be held.

 Division of Translational Research Promotion consists of three sections: Translational Research Collaboration Support Section, Translational Research Specimen Control Section, and Translational Research Promotion Section. The Translational Research Collaboration Support Section is bridging the TR studies conducted as clinical studies in the Hospital when supported by the Research Institute, and supporting the management of bioresources collected in the Hospital. The Translational Research Specimen Control Section supports the logistics of TR researches utilizing patient-derived hematologic and tissue samples performed in the departments of the Hospital. The Translational Research Promotion Section promotes reverse TR in conjunction with clinicals and supports TR studies conducted by junior clinicians. It is composed of one director and five members.

 Division of Medical Device Innovation Promotion: Based on the development of medical devices in conjunction with MIRAI project, it aims to be a world-class center for the development of minimally invasive treatments and medical devices by introducing AI and robotics technologies, to develop useful products for cancer patients regardless of whether they are medical devices or non-medical devices, and to make use of the ATLAS project's platform for international development. It has now begun with programmed medical devices and has been cross-sectionally promoting the development of novel medical devices in various clinical departments supported by MIRAI Project.

Research Activities

 Division of Drug and Diagnostic Development Promotion: In fiscal 2024, our division managed the progress and promoted patient enrollment for 13 cross-organ clinical trials. To promote the registration of clinical trials, multiple hospitals in Kanto region were visited to introduce the clinical trials being conducted in our hospital, and the cooperation for the promotion of the referral of patients was strengthened. In January 2025, we held a workshop for healthcare professionals, including physicians and CRCs, with the aim of deepening their knowledge of clinical research and clinical trials and enhancing their literacy in these areas. In March 2025, we held a briefing session to introduce our department's initiatives for promoting cross-organ clinical trials to pharmaceutical companies and CROs, and worked on strengthening collaboration with these companies.

 Division of Translational Research Promotion: The Translational Research Collaboration Support Section supported physician-initiated clinical trials and ancillary studies of clinical trials in fiscal 2023, including 1 respiratory medicine, 3 medical oncology, 3 pediatric oncology, 1 advanced care department, and 1 osteochondral oncology. In addition, by March 2024, a total of 2023 enrollments (108 cases/year) and 638 engraftments (63 cases/year) had been generated in J-PDx project to create a PDx modeling using patient-derived samples that could be collected with comprehensive consent and individual consent in the Hospital. The Translational Research Specimen Control Section supported 26 trials (eight starting in fiscal year 2024) as of March 2024. In collaboration with the Department of Laboratory Medicine, a system for managing blood collection tubes for research in the blood collection room was developed and improved, so that the patients themselves do not have to bring them, and blood collection is now performed more on schedule. Currently, we are preparing to assist with implementation planning such as prospective whole-genome analyses associated with JCOG trials. Translational Research Promotion Section provides support for 7 issues in fiscal 2023, and is preparing 14 studies for support in conjunction with the Research Institute FIOC.

 Division of Medical Device Innovation Promotion: Beginning with programmed medical devices, we are promoting the development of new medical devices, including 11 in the Department of Endoscopy, 6 in IVR Center, 3 in the Department of Hepatobiliary and Pancreatic Surgery, 3 in the Department of Hepatobiliary and Pancreatic Oncology, 3 in the Department of Radiation Oncology and 3 in the Department of Musculoskeletal Oncology and Rehabilitation. The final milestones are from regulatory approval to commercialization and insurance reimbursement, respectively.

Education

 The development of the next generation of development researchers is being carried out through medical care and research, which is not only in Japan but also globally. The training object is not limited to doctors, and it is made to be multi-occupation such as nurses, pharmacists, clinical laboratory technicians, etc.

Future Prospects

 Recent development of cancer therapy is remarkably internationalized, diversified and accelerated, and its by-products can be called drug loss. In order to respond to the rapidly changing development of cancer treatments, we hope to promote human resource development while flexibly absorbing changes, and to lead the development of cancer treatments in Japan.

List of papers published in 2024

Journal

1. Parasa S, Berzin T, Leggett C, Gross S, Repici A, Ahmad OF, Chiang A, Coelho-Prabhu N, Cohen J, Dekker E, Keswani RN, Kahn CE, Hassan C, Petrick N, Mountney P, Ng J, Riegler M, Mori Y, Saito Y, Thakkar S, Waxman I, Wallace MB, Sharma P. Consensus statements on the current landscape of artificial intelligence applications in endoscopy, addressing roadblocks, and advancing artificial intelligence in gastroenterology. Gastrointestinal endoscopy, 101:2-9.e1, 2025

2. Sakamoto T, Oda I, Okamura T, Cho H, Toyoshima N, Nonaka S, Suzuki H, Nakamura T, Watanabe D, Matsuo K, Hanano K, Takeyama T, Yoshinaga S, Saito Y. Exploratory investigation of virtual lesions in gastrointestinal endoscopy using a novel phase-shift method for three-dimensional shape measurement. DEN open, 5:e381, 2025

3. Yazaki S, Chiba Y, Kojima Y, Yoshida H, Takamizawa S, Kitadai R, Saito A, Kita S, Yamamoto K, Sumiyoshi-Okuma H, Nishikawa T, Sudo K, Shimoi T, Noguchi E, Uno M, Ishikawa M, Kato T, Fujiwara Y, Yonemori K. Folate Receptor Alpha Expression and the Tumor Immune Microenvironment in Patients with Cervical Cancer. International journal of gynecological pathology, 44:104-111, 2025

4. Mizoguchi C, Nishikawa T, Yoshida H, Yasuda M, Kato T, Hasegawa K, Yonemori K. HER2-negative or low expression as an unfavorable prognostic factor in patients with stage I/II uterine carcinosarcoma. Journal of gynecologic oncology, 36:e14, 2025

5. Mizutani S, Tamaki A, Shiba S, Salim F, Yamada M, Takamaru H, Nakajima T, Yoshida N, Ikuta S, Yachida T, Shibata T, Soga T, Saito Y, Fukuda S, Ishikawa H, Yamada T, Yachida S. Dynamics of the gut microbiome in FAP patients undergoing intensive endoscopic reduction of polyp burden. Gut, 74:335-338, 2025

6. Goto O, Morita Y, Takayama H, Hirasawa K, Sato C, Oyama T, Takahashi A, Abe S, Saito Y, Ono H, Kawata N, Otsuka T, Iwakiri K. Endoscopic hand suturing has the potential to reduce bleeding after gastric endoscopic submucosal dissection in patients on antithrombotic agents: Multicenter phase II study. Digestive endoscopy, 37:266-274, 2025

7. Wilding B, Woelflingseder L, Baum A, Chylinski K, Vainorius G, Gibson N, Waizenegger IC, Gerlach D, Augsten M, Spreitzer F, Shirai Y, Ikegami M, Tilandyová S, Scharn D, Pearson MA, Popow J, Obenauf AC, Yamamoto N, Kondo S, Opdam FL, Bruining A, Kohsaka S, Kraut N, Heymach JV, Solca F, Neumüller RA. Zongertinib (BI 1810631), an Irreversible HER2 TKI, Spares EGFR Signaling and Improves Therapeutic Response in Preclinical Models and Patients with HER2-Driven Cancers. Cancer discovery, 15:119-138, 2025

8. Hirai Y, Toyoshima N, Saito Y. Endoscopic Resection for Colorectal Tumors. Digestion, 106:115-121, 2025

9. Pattarajierapan S, Saito Y, Takamaru H, Toyoshima N, Wisedopas N, Wanpiyarat N, Lerttanatum N, Khomvilai S. Learning curve of colorectal endoscopic submucosal dissection of an endoscopist experienced hands-on training in Japan. Journal of gastroenterology and hepatology, 40:226-234, 2025

10. Hamamoto R, Komatsu M, Yamada M, Kobayashi K, Takahashi M, Miyake M, Jinnai S, Koyama T, Kouno N, Machino H, Takahashi S, Asada K, Ueda N, Kaneko S. Current status and future direction of cancer research using artificial intelligence for clinical application. Cancer science, 116:297-307, 2025

11. Iwata H, Naito Y, Hattori M, Yoshimura A, Yonemori K, Aizawa M, Mori Y, Yoshimitsu J, Umeyama Y, Mukohara T. Safety and pharmacokinetics of vepdegestrant in Japanese patients with ER+ advanced breast cancer: a phase 1 study. International journal of clinical oncology, 30:72-82, 2025

12. Hotta K, Matsuda T, Sano Y, Fujii T, Saito Y. Surveillance after Endoscopic Resection for Colorectal Tumors: A Comprehensive Review. Digestion, 106:131-137, 2025

13. Liu J, Farrow M, Seymour L, Desai J, Loong HH, Ivy P, Koyoma T, Cook N, Blagden S, Garralda E, Massard C, Tolcher AW, Adashek JJ, Zhang L, Zhao S, Shen L, Kurzrock R, El-Deiry WS, Subbiah V, Joshua AM. Accelerating the Future of Oncology Drug Development: The Role of Consortia in the Delivery of Precision Oncology Early Phase Clinical Trials. Journal of clinical oncology, 43:735-747, 2025

14. Masuda K, Yoshida T, Motoi N, Shinno Y, Matsumoto Y, Okuma Y, Goto Y, Horinouchi H, Yamamoto N, Watanabe SI, Hoshino T, Yatabe Y, Ohe Y. Schlafen 11 Expression in Patients With Small Cell Lung Cancer and Its Association With Clinical Outcomes. Thoracic cancer, 16:e15529, 2025

15. Shirasawa M, Yoshida T, Matsutani T, Takeyasu Y, Goto N, Yagishita S, Kitano S, Kuroda H, Hida T, Kurata T, Ohe Y. Diversity of TCR repertoire predicts recurrence after CRT followed by durvalumab in patients with NSCLC. NPJ precision oncology, 9:17, 2025

16. Takahashi Y, Yoshida A, Yoshimoto S, Suzuki S, Kishikawa S, Mitsui A, Ryo E, Kojima Y, Yonemori K, Yatabe Y, Mori T. TFE3-rearranged perivascular epithelioid cell tumors of the head and neck with rare fusion partners: clues to the differential diagnosis between benign and malignant tumors. Diagnostic pathology, 20:7, 2025

17. Katsuya Y, Ikeda M, Koyama T, Sato J, Okada M, Matsubara N, Kondoh C, Mukohara T, Watanabe K, Kotani D, Ogawa Y, Taoka S, Yamamoto N. A Phase I, First-In-Human Study of CBA-1205, an Anti-DLK1 Monoclonal Antibody, in Patients With Advanced Solid Tumors. Cancer science, 116:1012-1022, 2025

18. Romańczyk M, Desai M, Kamiński MF, Abe S, Alkandari AA, Beyna T, Bisschops R, Budzyń K, Bugdol M, Grover SC, Gyawali CP, Inoue H, Iyer PG, Messmann H, Ragunath K, Saito Y, Srinivasan S, Teshima C, Yadlapati R, Hassan C, Sharma P. International Validation of a Novel PEACE Scale to Improve the Quality of Upper Gastrointestinal Mucosal Inspection During Endoscopy. Clinical and translational gastroenterology, 16:e00786, 2025

19. Hayato S, Hamuro L, Shimizu T, Yonemori K, Nishio S, Yunokawa M, Yoshida T, Nishio M, Matsumoto K, Takehara K, Hasegawa K, Kozuki T, Hirashima Y, Kato H, Miura T, Nomoto M, Zhao Y, Zhu L, Yasuda S. Pharmacokinetic and Exposure-Response Modeling Support Body Surface Area-Based Dosing of Farletuzumab Ecteribulin in Japanese Patients with Solid Tumors. Journal of clinical pharmacology, 65:751-762, 2025

20. Fujii E, Kato MK, Ono H, Yamaguchi M, Higuchi D, Koyama T, Komatsu M, Hamamoto R, Ishikawa M, Kato T, Kohno T, Shiraishi K, Yoshida H. TP53 Mutations and PD-L1 Amplification in Vulvar Adenocarcinoma of the Intestinal Type: Insights From Whole Exome Sequencing of 2 Cases. International journal of gynecological pathology, 44:358-363, 2025

21. Takamaru H, Tsay C, Shiba S, Yachida S, Saito Y. Microbiome and Colorectal Cancer in Humans: A Review of Recent Studies. Journal of the anus, rectum and colon, 9:20-24, 2025

22. Yamashige D, Hijioka S, Nagashio Y, Maruki Y, Fukuda S, Yagi S, Okamoto K, Hara H, Hagiwara Y, Agarie D, Takasaki T, Ohba A, Kondo S, Morizane C, Ueno H, Sone M, Saito Y, Okusaka T. Potential of 6-mm-diameter fully covered self-expandable metal stents for unresectable malignant distal biliary obstruction: a propensity score-matched study. Clinical endoscopy, 58:121-133, 2025

23. Nishimura R, Sudo K, Kitadai R, Kawachi A, Ito M, Hoshino M, Kita S, Saito A, Kojima Y, Maejima A, Noguchi E, Okuma HS, Koyama T, Shimoi T, Yonemori K. Treatment and Reasons for Choosing Treatment in Breast Cancer Patients Who Underwent Next-Generation Sequencing Test. Oncology, 1-10, 2025

24. Fujii H, Okuma Y, Hirata M, Shinno Y, Yoshida T, Goto Y, Horinouchi H, Yamamoto N, Ohe Y. EGFR-Mutated Lung Adenocarcinoma With Li-Fraumeni Syndrome: The Imperative for Germline Testing in Patients With a Family History, a Case Report. JTO clinical and research reports, 6:100691, 2025

25. Kitadai R, Yazaki S, Kuchiba A, Yamanaka T, Shiino S, Yamauchi C, Harano K, Saito M, Hirotsu Y, Aiba H, Yoshida T, Hamamoto R, Shimizu C, Shimomura A, Kojima Y, Shimoi T, Momozawa Y, Sudo K, Yoshida M, Sunami K, Hori M, Katanoda K, Shimada Y, Yamashita Y, Kogawa T, Murata T, Fujiwara S, Miyagi Y, Nakagomi H, Tachibana K, Omata M, Ohtake T, Suto A, Onishi T, Naito Y, Yamashita T, Yonemori K, Kohno T, Shiraishi K. Germline Pathogenic Variants and Clinical Outcomes in Asian Patients With Breast Cancer. Cancer science, 116:1048-1058, 2025

26. Takeuchi T, Horinouchi H, Takasawa K, Mukai M, Masuda K, Shinno Y, Okuma Y, Yoshida T, Goto Y, Yamamoto N, Ohe Y, Miyake M, Watanabe H, Kusumoto M, Aoki T, Nishimura K, Hamamoto R. A series of natural language processing for predicting tumor response evaluation and survival curve from electronic health records. BMC medical informatics and decision making, 25:85, 2025

27. Satoh H, Okuma Y, Shinno Y, Masuda K, Matsumoto Y, Yoshida T, Goto Y, Horinouchi H, Yamamoto N, Ohe Y. Evolving treatments and prognosis in Stage IV non-small cell lung cancer: 20 years of progress of novel therapies. Lung cancer (Amsterdam, Netherlands), 202:108453, 2025

28. Heymach JV, Opdam F, Barve M, Tu HY, Wu YL, Berz D, Schröter L, Botilde Y, Sadrolhefazi B, Serra J, Yoh K, Yamamoto N. HER2-Selective Tyrosine Kinase Inhibitor, Zongertinib (BI 1810631), in Patients With Advanced/Metastatic Solid Tumors With HER2 Alterations: A Phase Ia Dose-Escalation Study. Journal of clinical oncology, 43:1337-1347, 2025

29. Nassar AH, Abou Alaiwi S, El Zarif T, Denu R, Macaron W, Abdel-Wahab N, Freeman D, Vasbinder A, Hayeck S, Anderson E, Goodman RS, Johnson DB, Grynberg S, Shapira R, Kwan JM, Woodford R, Long GV, Haykal T, Dent S, Kojima Y, Yonemor K, Tandon A, Trevino A, Akhter N, Yang EH, Hui G, Drakaki A, El-Am E, Kozaily E, Al-Hader A, Bou Farhat E, Babu P, Mittra A, Li M, Jones N, Baena J, Juarez Herrera M, Foderaro S, Nana FA, Kim C, Sackstein P, Parikh K, Desai AP, Smith C, Cortellini A, Pinato DJ, Korolewicz J, Lopetegui-Lia N, Funchain P, Choudhary A, Asnani A, Navani V, Meyers D, Stukalin I, Ocejo Gallegos JA, Trent J, Nusrat S, Malvar C, McKay RR, Neilan TG, Choueiri TK, Naqash AR. Safety and efficacy of immune checkpoint therapy for the treatment of patients with cardiac metastasis: a multicenter international retrospective study. Journal for immunotherapy of cancer, 13:e009364, 2025

30. Hara H, Hijioka S, Yamashige D, Nagashio Y, Komori Y, Kuwada M, Fukuda S, Yagi S, Okamoto K, Agarie D, Chatto M, Okada M, Maruki Y, Morizane C, Ueno H, Saito Y, Yonemori K, Okusaka T. Clinical significance and efficacy of endoscopic ultrasound-guided tissue acquisition for para-aortic lymph node metastasis. Digestive endoscopy, 2025

31. Torasawa M, Yoshida T, Shiraishi K, Yagishita S, Ono H, Uehara Y, Miyakoshi J, Tateishi A, Igawa YS, Higashiyama RI, Mochizuki A, Masuda K, Matsumoto Y, Shinno Y, Okuma Y, Goto Y, Horinouchi H, Hamamoto R, Yamamoto N, Watanabe SI, Yatabe Y, Takahashi K, Kohno T, Ohe Y. Implications of EGFR expression on EGFR signaling dependency and adaptive immunity against EGFR-mutated lung adenocarcinoma. Lung cancer (Amsterdam, Netherlands), 202:108494, 2025

32. Imai T, Shimoi T, Kawai A, Yonemori K. Diagnosis and treatment of cardiac tumors. Medical oncology (Northwood, London, England), 42:110, 2025

33. Kitadai R, Okuma Y, Shibata T, Kohno T, Koyama T. Tissue-agnostic target profiles and treatment efficacy in cancer patients: Insights from the C-CAT clinicogenomic repository. European journal of cancer (Oxford, England : 1990), 220:115380, 2025

34. Seto T, Nakane S, Ji L, Ueda Y, Sugano H, Takei N, Kobayashi M, Murayama A, Yamamoto N. Real-world safety and effectiveness of entrectinib in Japanese patients with ROS1 gene fusion-positive, unresectable, advanced/recurrent non-small cell lung cancer: Post-marketing surveillance. Lung cancer (Amsterdam, Netherlands), 203:108478, 2025

35. Uehara Y, Koyama T, Katsuya Y, Sato J, Sudo K, Kondo S, Yoshida T, Shoji H, Shimoi T, Okada M, Yonemori K, Yamamoto N. Impact of travel costs on disparities in precision oncology clinical trials. ESMO Real World Data and Digital Oncology, 7:100114, 2025

36. Saito Y, Sakamoto T, Dekker E, Pioche M, Probst A, Ponchon T, Messmann H, Dinis-Ribeiro M, Matsuda T, Ikematsu H, Saito S, Wada Y, Oka S, Sano Y, Fujishiro M, Murakami Y, Ishikawa H, Inoue H, Tanaka S, Tajiri H. First report from the International Evaluation of Endoscopic classification Japan NBI Expert Team: International multicenter web trial. Digestive endoscopy, 36:591-599, 2024

37. Fukushima T, Goto K, Hayashi T, Ikeda K, Hatayama T, Yamanaka R, Iwane K, Tasaka R, Kohada Y, Takemoto K, Kobatake K, Goriki A, Toshida A, Nakahara H, Motonaga M, Tokumo K, Fujii Y, Hayes CN, Okamoto W, Kubo T, Matsumoto T, Shiota M, Yamamoto N, Urabe Y, Hiyama E, Arihiro K, Hinoi T, Hinata N. Comprehensive genomic profiling testing in Japanese castration-resistant prostate cancer patients: results of a single-center retrospective cohort study. Japanese journal of clinical oncology, 54:175-181, 2024

38. Ito S, Hotta K, Sekiguchi M, Takeuchi Y, Oka S, Yamamoto H, Shinmura K, Harada K, Uraoka T, Hisabe T, Sano Y, Kondo H, Horimatsu T, Kikuchi H, Kawamura T, Nagata S, Yamamoto K, Tajika M, Tsuji S, Kusaka T, Okuyama Y, Yoshida N, Moriyama T, Hasebe A, So S, Saito Y, Nakahira H, Ishikawa H, Matsuda T. Short-term outcomes of endoscopic resection for colorectal neuroendocrine tumors: Japanese multicenter prospective C-NET STUDY. Digestive endoscopy, 36:942-951, 2024

39. Mandarino FV, Danese S, Uraoka T, Parra-Blanco A, Maeda Y, Saito Y, Kudo SE, Bourke MJ, Iacucci M. Precision endoscopy in colorectal polyps' characterization and planning of endoscopic therapy. Digestive endoscopy, 36:761-777, 2024

40. Janku F, Kim TM, Iyer G, Spreafico A, Elez E, de Jonge M, Yamamoto N, van der Wekken AJ, Ascierto PA, Maur M, Marmé F, Kiladjian JJ, Basu S, Baffert F, Buigues A, Chen C, Cooke V, Giorgetti E, Kim J, McCarthy F, Moschetta M, Dummer R. First-in-human study of naporafenib (LXH254) with or without spartalizumab in adult patients with advanced solid tumors harboring MAPK signaling pathway alterations. European journal of cancer (Oxford, England : 1990), 196:113458, 2024

41. Ando Y, Shimoi T, Sunami K, Okita N, Nakamura K, Shibata T, Fujiwara Y, Yamamoto N. Progress report of a cross-organ and biomarker-based basket-type clinical trial: BELIEVE Trial. Cancer science, 115:555-563, 2024

42. Doi T, Yamamoto N, Ohkubo S. Pimitespib for the treatment of advanced gastrointestinal stromal tumors and other tumors. Future oncology (London, England), 20:507-519, 2024

43. Matsubara N, Kusuhara S, Yamamoto N, Sudo K, Yanagita M, Murayama K, Kawasumi H, Russell DL, Yin D, Shimizu T. Safety and pharmacokinetics of imaradenant (AZD4635) in Japanese patients with advanced solid malignancies: a phase I, open-label study. Cancer chemotherapy and pharmacology, 93:341-352, 2024

44. Ishimaru S, Shimoi T, Sunami K, Nakajima M, Ando Y, Okita N, Nakamura K, Shibata T, Fujiwara Y, Yamamoto N. Platform trial for off-label oncology drugs using comprehensive genomic profiling under the universal public healthcare system: the BELIEVE trial. International journal of clinical oncology, 29:89-95, 2024

45. Nishio M, Murakami S, Kawakami H, Okishio K, Tamiya M, Kobayashi H, Fujimoto D, Sugawara S, Kozuki T, Oya Y, Izumi H, Shiroyama T, Satouchi M, Yamamoto N, Kaname S, Matsuoka D, Otake Y, Takase T, Semba T, Azuma K. Phase II Study of the Liposomal Formulation of Eribulin (E7389-LF) in Combination with Nivolumab: Results from the Small Cell Lung Cancer Cohort. Cancer research communications, 4:226-235, 2024

46. Yamamoto N, Koyama T, Sato J, Yoshida T, Sudo K, Iwasa S, Kondo S, Yonemori K, Kawasaki A, Satake K, Shibata S, Shimizu T. Phase I study of the anti-TIGIT antibody tiragolumab in combination with atezolizumab in Japanese patients with advanced or metastatic solid tumors. Cancer chemotherapy and pharmacology, 94:109-115, 2024

47. Cho H, Abe S, Nonaka S, Suzuki H, Yoshinaga S, Okuma K, Yamamoto S, Daiko H, Kato K, Sekine S, Boku N, Saito Y. Long-term outcomes after non-curative endoscopic resection for esophageal squamous cell carcinoma followed by additional chemoradiotherapy. Diseases of the esophagus, 37:doae004, 2024

48. Kawazoe A, Yamamoto N, Sugimoto N, Kawakami H, Oshima T, Yamaguchi K, Hino K, Hirao M, Kurokawa Y, Kawakami T, Tsuda M, Hara H, Kaname S, Matsuoka D, Otake Y, Yasuda K, Takase T, Takashima S, Semba T, Muro K. Phase II Study of the Liposomal Formulation of Eribulin (E7389-LF) in Combination with Nivolumab: Results from the Gastric Cancer Cohort. Clinical cancer research, 30:1264-1272, 2024

49. Fujita K, Saito Y. A novel hood with a small-caliber tip and two traction strings for endoscopic submucosal dissection. Endoscopy, 56:E111-E113, 2024

50. Shimoi T, Sunami K, Tahara M, Nishiwaki S, Tanaka S, Baba E, Kanai M, Kinoshita I, Shirota H, Hayashi H, Nishida N, Kubo T, Mamesaya N, Ando Y, Okita N, Shibata T, Nakamura K, Yamamoto N. Dabrafenib and trametinib administration in patients with BRAF V600E/R or non-V600 BRAF mutated advanced solid tumours (BELIEVE, NCCH1901): a multicentre, open-label, and single-arm phase II trial. EClinicalMedicine, 69:102447, 2024

51. Oka S, Tanaka S, Kajiwara Y, Saito S, Fukunaga Y, Takamatsu M, Kawachi H, Hotta K, Ikematsu H, Kojima M, Saito Y, Yamada M, Kanemitsu Y, Sekine S, Nagata S, Yamada K, Kobayashi N, Ishihara S, Saitoh Y, Matsuda K, Togashi K, Komori K, Ishiguro M, Kuwai T, Okuyama T, Ohuchi A, Ohnuma S, Sakamoto K, Sugai T, Katsumata K, Matsushita HO, Yamano HO, Eda H, Uraoka T, Akimoto N, Kobayashi H, Sugihara K, Ueno H. Treatment Decision for Locally Resected T1 Colorectal Carcinoma-Verification of the Japanese Guideline Criteria for Additional Surgery Based on Long-Term Clinical Outcomes. The American journal of gastroenterology, 119:2019-2027, 2024

52. Takeyasu Y, Yoshida T, Masuda K, Matsumoto Y, Shinno Y, Okuma Y, Goto Y, Horinouchi H, Yamamoto N, Ohe Y. Distinct Progression and Efficacy of First-Line Osimertinib Treatment According to Mutation Subtypes in Metastatic NSCLC Harboring EGFR Mutations. JTO clinical and research reports, 5:100636, 2024

53. Shirai Y, Ueno T, Kojima S, Ikeuchi H, Kitada R, Koyama T, Takahashi F, Takahashi K, Ichimura K, Yoshida A, Sugino H, Mano H, Narita Y, Takahashi M, Kohsaka S. The development of a custom RNA-sequencing panel for the identification of predictive and diagnostic biomarkers in glioma. Journal of neuro-oncology, 167:75-88, 2024

54. Katsuya Y, Yoshida T, Takashima A, Yonemori K, Ohba A, Yazaki S, Yagishita S, Nakahama H, Kobayashi O, Yanagida M, Irino Y, Hamada A, Yamamoto N. Immunogenicity after vaccination of COVID-19 vaccines in patients with cancer: a prospective, single center, observational study. International journal of clinical oncology, 29:386-397, 2024

55. Saito Y. Top tips for performing high-quality optical zoom chromocolonoscopy (with video). Gastrointestinal endoscopy, 100:122-127, 2024

56. Sasaki A, Takeshima H, Yamashita S, Ichita C, Kawachi J, Naito W, Ohashi Y, Takeuchi C, Fukuda M, Furuichi Y, Yamamichi N, Ando T, Kobara H, Kotera T, Itoi T, Sumida C, Hamada A, Koizumi K, Ushijima T. Severe induction of aberrant DNA methylation by nodular gastritis in adults. Journal of gastroenterology, 59:442-456, 2024

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