Kohei Shitara
设乐研也
MD
Chief, Department of Gastrointestinal Oncology, National Cancer Center Hospital East日本国立癌症研究中心东医院消化道肿瘤科主任
👥Biography 个人简介
Kohei Shitara, MD is Chief of the Department of Gastrointestinal Oncology at the National Cancer Center Hospital East in Japan. He is one of the world's most prominent clinical researchers in gastric and gastroesophageal junction cancer and a leading figure in the global development of novel targeted therapies for upper GI malignancies. Dr. Shitara is internationally recognized as the principal investigator of the DESTINY-Gastric01 and DESTINY-Gastric02 trials, which established trastuzumab deruxtecan (T-DXd) as a breakthrough treatment for HER2-positive gastric cancer after trastuzumab-based first-line therapy, achieving unprecedented response rates and earning accelerated FDA approval. He was also a key investigator in the ATTRACTION-2 trial that established nivolumab in Asian patients with heavily pretreated gastric cancer. Dr. Shitara has been instrumental in expanding the use of immunotherapy and ADCs across lines of therapy in gastric cancer and has led numerous investigator-initiated and cooperative group trials in Japan and globally. He serves on the editorial boards of leading oncology journals and is a frequent invited lecturer at ASCO, ESMO, and JSMO.
🧪Research Fields 研究领域
🎓Key Contributions 主要贡献
DESTINY-Gastric01/02 — Trastuzumab Deruxtecan in HER2+ Gastric Cancer
Led DESTINY-Gastric01 (Japan/Korea) and DESTINY-Gastric02 (Western populations) trials demonstrating that T-DXd achieved response rates of approximately 40–51% in HER2-positive gastric/GEJ cancer after prior trastuzumab, representing a transformative improvement over standard salvage chemotherapy and earning FDA accelerated approval.
ATTRACTION-2 — Nivolumab in Heavily Pretreated Asian Gastric Cancer
Participated in the ATTRACTION-2 phase III trial, the first randomized controlled study to demonstrate an overall survival benefit of an anti-PD-1 agent over placebo in third-line or later advanced gastric/GEJ cancer predominantly in Asian patients, informing regional regulatory approvals and the role of PD-1 inhibition in late-line settings.
Ramucirumab plus Paclitaxel — Second-Line Gastric Cancer
Contributed extensively to the RAINBOW Asia trial and ramucirumab clinical development in Japan, helping establish VEGFR2 inhibition combined with paclitaxel as a second-line standard and characterizing efficacy in Asian gastric cancer populations with distinct tumor biology.
Biomarker Strategy for ADC and HER2-Directed Therapy in Gastric Cancer
Led correlative analyses from DESTINY-Gastric trials characterizing HER2 expression heterogeneity, IHC scoring, and mechanisms of resistance to T-DXd in gastric cancer, establishing a framework for patient selection and sequencing of ADC-based therapies in HER2-low and HER2-positive disease.
Representative Works 代表性著作
Trastuzumab deruxtecan in previously treated HER2-positive gastric cancer (DESTINY-Gastric01): A randomized, open-label, phase 2 trial
The Lancet Oncology (2020)
DESTINY-Gastric01 demonstrating T-DXd achieved 51% ORR versus 14% with chemotherapy in HER2-positive gastric/GEJ cancer, leading to accelerated FDA approval.
Nivolumab versus chemotherapy in patients with advanced oesophageal squamous cell carcinoma refractory or intolerant to previous chemotherapy (ATTRACTION-3)
The Lancet Oncology (2019)
Phase III trial establishing nivolumab as a second-line standard in advanced esophageal squamous cell carcinoma with improved survival versus chemotherapy.
Pembrolizumab versus paclitaxel for previously treated, advanced gastric or gastro-oesophageal junction cancer (KEYNOTE-061)
The Lancet (2018)
Phase III KEYNOTE-061 evaluating pembrolizumab versus paclitaxel in second-line gastric/GEJ cancer with exploratory PD-L1 and MSI subgroup analyses.
Nivolumab in patients with advanced gastric or gastro-oesophageal junction cancer refractory to, or intolerant of, at least two previous chemotherapy regimens (ONO-4538-12, ATTRACTION-2)
The Lancet (2017)
ATTRACTION-2 phase III trial demonstrating nivolumab improved overall survival versus placebo in heavily pretreated Asian patients with advanced gastric/GEJ cancer.
🏆Awards & Recognition 奖项与荣誉
📄Data Sources 数据来源
Last updated: 2026-04-06 | All information from publicly available academic sources
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