{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T20:58:00Z","timestamp":1790974680572,"version":"4.1.0"},"reference-count":24,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2024,2,7]],"date-time":"2024-02-07T00:00:00Z","timestamp":1707264000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Merck Sharp & Dohme LLC"},{"name":"Hoosier Cancer Research Network"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,3,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Combination checkpoint inhibition therapy with yttrium-90 (Y90) radioembolization represents an emerging area of interest in the treatment of advanced hepatocellular carcinoma (HCC). HCRN GI15-225 is an open-label, single-arm multicenter, pilot study (NCT03099564).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Eligible patients had poor prognosis, localized HCC defined as having portal vein thrombus, multifocal disease, and\/or diffuse disease that were not eligible for liver transplant or surgical resection. Patients received pembrolizumab 200 mg intravenously every 3 weeks in conjunction with glass yttrium-90 (Y90) radioembolization TheraSphere. Primary endpoint was 6-month progression-free survival (PFS6) per RECIST 1.1. Secondary endpoints included time to progression (TTP), objective response rate (ORR), overall survival (OS), and safety\/tolerability.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Between October 23, 2017 and November 24, 2020, 29 patients were enrolled: 2 were excluded per protocol. Fifteen of the remaining 27 patients were free of progression at 6 months (55.6%; 95% CI, 35.3-74.5) with median PFS 9.95 months (95% CI, 4.14-15.24) and OS 27.30 months (95% CI, 10.15-39.52). One patient was not evaluable for response due to death; among the remaining 26 patients, ORR was 30.8% (95% CI, 14.3-51.8) and DCR was 84.6% (95% CI, 65.1-95.6).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>In patients with localized, poor prognosis HCC, pembrolizumab in addition to glass Y90 radioembolization demonstrated promising efficacy and safety consistent with prior observations (ClinicalTrials.gov Identifier: NCT03099564; IRB Approved: 16-3255 approved July 12, 2016).<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/oncolo\/oyad331","type":"journal-article","created":{"date-parts":[[2024,2,7]],"date-time":"2024-02-07T23:06:57Z","timestamp":1707347217000},"page":"270-e413","source":"Crossref","is-referenced-by-count":51,"title":["A Pilot Study of Pembrolizumab in Combination With Y90 Radioembolization in Subjects With Poor Prognosis Hepatocellular Carcinoma"],"prefix":"10.1093","volume":"29","author":[{"given":"Shawn","family":"Yu","sequence":"first","affiliation":[{"name":"Department of Medicine, The University of North Carolina at Chapel Hill , Chapel Hill, NC , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Menggang","family":"Yu","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, University of Michigan , Ann Arbor, MI , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barry","family":"Keane","sequence":"additional","affiliation":[{"name":"Department of Medicine, The University of North Carolina at Chapel Hill , Chapel Hill, NC , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David M","family":"Mauro","sequence":"additional","affiliation":[{"name":"Department of Medicine, The University of North Carolina at Chapel Hill , Chapel Hill, NC , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul R","family":"Helft","sequence":"additional","affiliation":[{"name":"Department of Medicine, Indiana University Simon Cancer Center , Indianapolis, IN , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William P","family":"Harris","sequence":"additional","affiliation":[{"name":"Department of Medicine, University of Washington\/FHCC , Seattle, WA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hanna K","family":"Sanoff","sequence":"additional","affiliation":[{"name":"Department of Medicine, The University of North Carolina at Chapel Hill , Chapel Hill, NC , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew S","family":"Johnson","sequence":"additional","affiliation":[{"name":"Department of Radiology and Imaging Sciences, Indiana University , Indianapolis, IN , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bert","family":"O\u2019Neil","sequence":"additional","affiliation":[{"name":"Community Health Network , Indianapolis, IN , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Autumn Jackson","family":"McRee","sequence":"additional","affiliation":[{"name":"Janssen Research & Development, LLC , Spring House, PA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3167-406X","authenticated-orcid":false,"given":"Ashwin","family":"Somasundaram","sequence":"additional","affiliation":[{"name":"Department of Medicine, The University of North Carolina at Chapel Hill , Chapel Hill, NC , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2024,2,7]]},"reference":[{"key":"2024030500082349700_CIT0001","first-page":"209","article-title":"Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 cancers in 185 countries","volume-title":"CA Cancer J 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Oncol","author":"Qin","year":"2022"},{"key":"2024030500082349700_CIT0015","first-page":"1894","article-title":"Atezolizumab plus bevacizumab in unresectable hepatocellular carcinoma","volume-title":"N Engl J Med","author":"Finn","year":"2020"},{"key":"2024030500082349700_CIT0016","first-page":"977","article-title":"Sintilimab plus a bevacizumab biosimilar (IBI305) versus sorafenib in unresectable hepatocellular carcinoma (ORIENT-32): a randomised, open-label, phase 2-3 study","volume-title":"Lancet Oncol","author":"Ren","year":"2021"},{"key":"2024030500082349700_CIT0017","first-page":"1434","article-title":"Pembrolizumab versus placebo as second-line therapy in patients from Asia with advanced hepatocellular carcinoma: a randomized, double-blind, phase III trial","volume-title":"J Clin Oncol","author":"Qin","year":"2023"},{"key":"2024030500082349700_CIT0018","first-page":"862","article-title":"Updated efficacy and safety data from IMbrave150: Atezolizumab plus bevacizumab vs sorafenib for unresectable hepatocellular carcinoma","volume-title":"J Hepatol","author":"Cheng","year":"2022"},{"key":"2024030500082349700_CIT0019","first-page":"1155","article-title":"Y90 radioembolization significantly prolongs time to progression compared with chemoembolization in patients with hepatocellular carcinoma","volume-title":"Gastroenterology","author":"Salem","year":"2016"},{"key":"2024030500082349700_CIT0020","first-page":"1025","article-title":"Radioembolisation with Y90-resin microspheres followed by nivolumab for advanced hepatocellular carcinoma (CA 209-678): a single arm, single centre, phase 2 trial","volume-title":"Lancet Gastroenterol Hepatol","author":"Tai","year":"2021"},{"key":"2024030500082349700_CIT0021","first-page":"345","article-title":"Stereotactic radiation therapy augments antigen-specific PD-1-mediated antitumor immune responses via cross-presentation of tumor antigen","volume-title":"Cancer Immunol 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