{"doi":"10.1093/oncolo/oyad331","title":"A Pilot Study of Pembrolizumab in Combination With Y90 Radioembolization in Subjects With Poor Prognosis Hepatocellular Carcinoma","abstract":"BACKGROUND: 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). METHODS: 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. RESULTS: 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). CONCLUSION: 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).","journal":"The Oncologist","year":2024,"id":418762,"datarank":1.3611387691220997,"base_score":3.8501476017100584,"endowment":3.8501476017100584,"self_citation_contribution":0.5775221402565088,"citation_network_contribution":0.7836166288655909,"self_endowment_contribution":0.5775221402565088,"citer_contribution":0.7836166288655909,"corpus_percentile":null,"corpus_rank":null,"citation_count":46,"citer_count":45,"citers_with_citation_signal":27,"citers_with_endowment":27,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9109,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT03099564"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2024-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":437916,"name":"Menggang Yu","orcid":"0000-0002-7904-3155","position":1,"is_corresponding":false},{"id":1207967,"name":"Barry Keane","orcid":null,"position":2,"is_corresponding":false},{"id":759538,"name":"David Mauro","orcid":"0000-0003-3088-1809","position":3,"is_corresponding":false},{"id":1207968,"name":"Paul R. Helft","orcid":null,"position":4,"is_corresponding":false},{"id":1207969,"name":"William Proctor Harris","orcid":null,"position":5,"is_corresponding":false},{"id":445404,"name":"Hanna K. Sanoff","orcid":"0000-0001-8679-4486","position":6,"is_corresponding":false},{"id":1207305,"name":"Matthew S. Johnson","orcid":"0000-0003-2892-1795","position":7,"is_corresponding":false},{"id":258832,"name":"Bert H. O’Neil","orcid":"0000-0001-7032-7453","position":8,"is_corresponding":false},{"id":844171,"name":"Autumn J. McRee","orcid":"0000-0002-0475-1579","position":9,"is_corresponding":false},{"id":258579,"name":"Ashwin Somasundaram","orcid":"0000-0003-3167-406X","position":10,"is_corresponding":false},{"id":1207304,"name":"Shawn Yu","orcid":"0000-0003-1951-2949","position":0,"is_corresponding":true}],"reference_count":48,"raw_metadata":null,"created_at":"2026-07-19T01:57:09.067930Z","pmid":"38325328","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}