Preface

The National Cancer Center (NCC) was selected as one of the five designated centers for early/exploratory clinical trial in 2011. With a budget support from the Japanese Ministry of Health, Labour and Welfare (MHLW), we organized "the Exploratory Oncology Research and Clinical Trial Center" (NCC-EPOC) through the Kashiwa and Tsukiji campuses in 2012, which focuses on early/exploratory clinical trials and translational research (TR). The NCC-EPOC was actually activated in April 2013 consisting of a phase I unit in each campus, a central/data center function unit for clinical trials, and a translational research (TR) unit. The TR unit additionally included the Division of Immunotherapy in July 2013. As for drug developments from Japan, three missions are focused on in the NCC-EPOC: to conduct first-in-human (FIH) trials, investigator-initiated trials (IITs) with unapproved agents, and TRs during early clinical studies. In addition to the drug development, the EPOC was integrated with the Research Center for Innovative Oncology (RCIO) in 2015 and has started developing medical equipment and accelerating higher quality TR in the NCC.

The activities in each unit in 2016 are described as follows.

1)Group for Clinical Research: The Division of Experimental Therapeutics consisting of several medical oncologists with backgrounds in each organ department was newly organized in both hospitals in order to conduct all-comer-type FIH/phase I studies. A regular weekly teleconference is held to collaborate with the two groups in each hospital. In 2016, several FIH/phase I trials including three IITs & TR were achieved in total at both hospitals. New seed subjects from outside academic research organizations have also been introduced.

2)Group for Translational Research: At the Tsukiji campus, we have been continuously improving an NGS testing system (NCC oncopanel system) to make a clinically useful in vitro diagnostics (IVD) system. Ninety-four tumor samples have been analyzed in the TOP-GEAR-2 study, in which NGS testing was performed with a high quality assurance in the SCI-Lab in the NCC-Hospital. This testing system was designated as an innovative pharmaceutical product in the SAKIGAKE Designation System of the MHLW, Japan. At the Kashiwa campus, whole exome analysis of occupational cholangiocarcinoma revealed hypermutation and unique mutational signatures. The SCRUM-Japan data center has been integrating clinical and genome data of more than 5,000 cases of lung and gastro-intestinal cancer with the collaboration of more than 200 academic institutes and 15 pharmaceutical companies.

3)Group for Innovative Cancer Treatment: Five divisions, 1) Pathology, 2) Developmental Therapeutics, 3) Cancer Immunotherapy, 4) Psycho-Oncology, and 5) Supportive Care Research have been focused on finding new seeds and a development of a new cancer treatment. A new immuno-monitoring system has been created in the Department of Pathology and Clinical Laboratories at the NCC-Hospital East by the Division of Cancer Immunology and freshly obtained specimens are being investigated.

4)Group for Innovative Diagnostic and Therapeutic Device: Five divisions, 1) Functional Imaging, 2) Radiation Oncology and Particle Therapy, 3) Boron Neutron Capture Therapy (BNCT), 4) Science and Technology for Endoscopy, and 5) Surgical Technology have innovated new medical equipment. We are aggressively developing new radiation therapies as intensity modulated radiation therapy and BNCT and are planning for clinical introduction in both campuses. In 2016, along with the Division of BNCT, the Division of Science and Technology for Endoscopy was created at the Tsukiji campus that facilitates the development of a new endoscopy equipment in collaboration with the Division of Science and Technology for Endoscopy of the Kashiwa campus.

Atsushi Ochiai, M.D., Ph.D.

Director

Exploratory Oncology Research & Clinical Trial Center