Annual Report 2020
Preface
One of the original units of the National Cancer Center, the National Cancer Center Hospital (NCCH) has led the nation’s cancer care and research, upholding its mission of ‘providing the best medicine to all citizens, working with the public.’ We drive clinical research in close cooperation with our Research Institute, in whole genome sequencing and translational research, develop treatments for rare and intractable cancers addressing unmet medical needs, work with international partners, strengthen safety as a designated Special Functioning Hospital, and deliver safe care and consultation services of high quality from the patients’ viewpoints.
In April 2020, the Tokyo metropolitan government requested special functioning hospitals to hospitalize Covid-19 patients. Although our specialty is with cancer, we prepared an isolated ward with 25 beds, two of which for severe cases, hospitalized and cared for 281 patients up till March 2021. 2366 PCR tests for SARS-CoV-2 were conducted (positive rate 0.59%) in-house, and a fever screening facility was set up in January 2021, isolated from other patients. Responding to the restrictions on inter-prefectural travel, we launched an online second opinion service for rare and intractable cancers in February 2021. All extra measures were carried out whilst minimizing its effects on normal cancer care.
Our clinical research support and governance has been reinforced, allowing for high volume and safe clinical research covering early to late phase development, responding to unmet medical needs. Preparations to obtain ISO 9001 certification, for quality management of clinical research were launched in 2020.
Building on our cancer care expertise and clinical research platform, we spearhead clinical trials and provide advanced therapeutics, as a clinical research core hospital. The total number of interventional and invasive investigator-initiated clinical trials was 276 as of March 2021. The new trials we started during fiscal 2020 are 108 industry-sponsored, 16 investigator-initiated, 76 multinational, and 19 first in human trials, as well as two advanced medical care. Our clinical research was more active than in 2019 in spite of the COVID-19 pandemic, and we delivered the world’s first drug for unresectable thymic carcinoma through an investigator-initiated trial (REMORA study: Sato J, et al. Lancet Oncol 2020; 21: 843-50.), successfully gaining approval.
We started initiatives with advanced medical care. The prospective study to assess the feasibility and clinical utility of gene panel test profiling upon initiating treatment of patients with solid tumors, Upfront NCC Oncopanel, was approved as advanced medical care B on April 1, 2020, and was conducted with the Hospital East. 91 patients were registered by the end of March 2021. Utilising the scheme of patient-proposed healthcare services, the trial with multiple targeted agents with multigene panel test profiling registered a total of 134 cases within FY2020. Twelve cancer genomic medicine core hospitals participated, with 18 drugs from 17 sponsors, some of which were also provided to children; eight drugs were provided at six participating hospitals. Tsukiji TR Board, the platform for translational research and reverse translational research was strengthened, three collaborative research projects were launched with pharmaceutical companies and startups.
In medical development, we continued the MASTER KEY project, an academia-industry collaborative registry study of rare cancer patients combined with multiple investigator-initiated trials. Launched in 2017, the initiative establishes a comprehensive database of rare cancers as historical control data, facilitating efficient investigator- and industry-initiated trials based on gene variants in the future. By the end of FY2020, 1613 patients with solid cancers, 168 patients with hematological cancers were enrolled, more than initially expected. Registered patients gained access to five industry-sponsored trials and nine investigator-initiated trials, whilst three more trials were prepared. Preparations towards expanding the scheme to Asia, MASTER KEY Asia, advanced.
MIRAI project (Minimally Invasive Revolutionary treatments with Advanced Intelligence) was launched in 2020, promoting the development of innovative medical devices much called for by society, and to nurture young talent driving the development of minimally invasive treatments. We are committed to integrating our innovative world-class gastrointestinal/respiratory endoscopy, pancreatic/biliary interventions, with interventional radiology, to deliver breakthrough minimally invasive treatments.
We launched ATLAS (Asian clinical TriaLs network for cAncerS) project with a grant from Japan Agency for Medical Research and Development (AMED). Building on our network with developed nations and regions in Asia, we shall support building infrastructures for clinical trials in the fast-growing ASEAN countries, establishing an early phase drug development network in Asia, provide equipment and capacity training programmes, employ specialists, and conduct multiple international collaborative clinical trials. Especially for rare cancers, industry-sponsored trials are limited, leading to limited treatment options; promoting investigator-initiated trials will help Asia address unmet needs in the region through collaboration, and by means of recruiting more cases in the wider region, it is anticipated that the development process for delivering new drugs will be accelerated. This clinical trial network in Asia shall drive drug development for the world.
During the year, the NCCH has launched several projects to realize our vision. We appreciate your understanding and support, as we report on fiscal year 2020.
National Cancer Center Hospital
The Director, Kazuaki Shimada