{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T23:28:01Z","timestamp":1789082881650,"version":"build-2803163510"},"reference-count":14,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2023,12,1]],"date-time":"2023-12-01T00:00:00Z","timestamp":1701388800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100009619","name":"Japan Agency for Medical Research and Development","doi-asserted-by":"publisher","award":["20ck0106622h0001"],"award-info":[{"award-number":["20ck0106622h0001"]}],"id":[{"id":"10.13039\/100009619","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100013170","name":"Ono Pharmaceutical","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100013170","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100007132","name":"Otsuka Pharmaceutical","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100007132","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Science"],"published-print":{"date-parts":[[2024,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Cancer genomic medicine using next\u2010generation sequencers has been developing. However, the number of patients who could receive genomically matched therapy is limited because off\u2010label use or patient\u2010oriented compassionate use was not permitted under National Health Insurance in Japan. To improve patient drug accessibility, we initiated a biomarker\u2010based basket\u2010type clinical trial (NCCH1901) in October 2019 under patient\u2010proposed healthcare services. We listed the drugs that had high medical needs but were not covered by National Healthcare Insurance. Then we included these drugs before patient proposal so that they could access off\u2010label drugs soon after they had the results of CGP tests. All drugs were provided free of charge by pharmaceutical companies. The objective was to administer off\u2010label drugs and to collect efficacy and safety data for these drugs. The primary endpoint was the response rate based on the best overall response for up to 16\u2009weeks. As of January 31, 2022, we included 18 drug cohorts and 295 patients were treated in this study. The most common cancer was brain tumor, followed by carcinoma of endocrine organs and colorectal cancer.\n                    <jats:italic>BRAF<\/jats:italic>\n                    mutations and\n                    <jats:italic>ERBB2<\/jats:italic>\n                    amplifications were the frequent genomic abnormalities to be enrolled. This study was one way to access off\u2010label drugs, and contributed significantly to providing treatment opportunities for patients in Japan.\n                  <\/jats:p>","DOI":"10.1111\/cas.16034","type":"journal-article","created":{"date-parts":[[2023,12,2]],"date-time":"2023-12-02T11:18:02Z","timestamp":1701515882000},"page":"555-563","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Progress report of a cross\u2010organ and biomarker\u2010based basket\u2010type clinical trial:\n                    <scp>BELIEVE<\/scp>\n                    Trial"],"prefix":"10.1111","volume":"115","author":[{"ORCID":"https:\/\/orcid.org\/0009-0000-0349-0832","authenticated-orcid":false,"given":"Yayoi","family":"Ando","sequence":"first","affiliation":[{"name":"Research Management Division, Clinical Research Support Office National Cancer Center Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tatsunori","family":"Shimoi","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology National Cancer Center Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7137-5649","authenticated-orcid":false,"given":"Kuniko","family":"Sunami","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine National Cancer Center Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Natsuko","family":"Okita","sequence":"additional","affiliation":[{"name":"Research Management Division, Clinical Research Support Office National Cancer Center Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3534-8296","authenticated-orcid":false,"given":"Kenichi","family":"Nakamura","sequence":"additional","affiliation":[{"name":"Department of International Clinical Development\/Clinical Research Support Office National Cancer Center Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Taro","family":"Shibata","sequence":"additional","affiliation":[{"name":"Statistics and Cancer Control Division, Research Center for Cancer Prevention and Screening National Cancer Center  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasuhiro","family":"Fujiwara","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology National Cancer Center Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0787-2851","authenticated-orcid":false,"given":"Noboru","family":"Yamamoto","sequence":"additional","affiliation":[{"name":"Department of Experimental Therapeutics National Cancer Center Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,12]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/cas.13969"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1093\/jjco\/hyaa028"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/cas.15517"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/cas.13730"},{"key":"e_1_2_12_6_1","unstructured":"Japanese Society of Medical Oncology Japan Society of Clinical Oncology and Japanese Cancer association.The guidance for cancer treatment based on gene panel testing using next\u2010generation sequencers (2.1 edition). Accessed September 18 2022.http:\/\/www.jca.gr.jp\/researcher\/topics\/2020\/files\/20200518.pdf"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1200\/OP.20.00131"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2006.06.8940"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-150-5-200903030-00109"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrd.2016.68"},{"key":"e_1_2_12_11_1","unstructured":"International Agency for Research on Cancer.The global Cancer Observatory. Accessed September 3 2023.https:\/\/gco.iarc.fr\/today\/data\/factsheets\/cancers\/39\u2010All\u2010cancers\u2010fact\u2010sheet.pdf"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/cas.15586"},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/djz245"},{"key":"e_1_2_12_14_1","unstructured":"Ministry of Health Labour and Welfare.A working group about the Guideline for Maintenance of Designated Core Hospitals for CGM. Accessed September 3 2023.https:\/\/www.mhlw.go.jp\/stf\/newpage_26592.html"},{"key":"e_1_2_12_15_1","unstructured":"Ministry of Health Labour and Welfare.A notification stating the utility of the results of clinical trials under the Clinical Trials Act for drug approval or label change. Accessed September 3 2023.https:\/\/www.mhlw.go.jp\/hourei\/doc\/tsuchi\/T230403I0190.pdf"}],"container-title":["Cancer Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cas.16034","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,3,12]],"date-time":"2024-03-12T03:22:18Z","timestamp":1710213738000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/cas.16034"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,12]]},"references-count":14,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2024,2]]}},"alternative-id":["10.1111\/cas.16034"],"URL":"https:\/\/doi.org\/10.1111\/cas.16034","archive":["Portico"],"relation":{},"ISSN":["1347-9032","1349-7006"],"issn-type":[{"value":"1347-9032","type":"print"},{"value":"1349-7006","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,12]]},"assertion":[{"value":"2023-09-27","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-11-17","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-12-01","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}