{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,16]],"date-time":"2026-02-16T20:59:23Z","timestamp":1771275563573,"version":"3.50.1"},"reference-count":37,"publisher":"Oxford University Press (OUP)","issue":"12","license":[{"start":{"date-parts":[[2023,6,17]],"date-time":"2023-06-17T00:00:00Z","timestamp":1686960000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004761","name":"Natural Science Foundation of Hainan Province","doi-asserted-by":"publisher","award":["820QN403"],"award-info":[{"award-number":["820QN403"]}],"id":[{"id":"10.13039\/501100004761","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Scientific Research Project of Higher Education in Hainan Province","award":["Hnky2022-34"],"award-info":[{"award-number":["Hnky2022-34"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,12,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>For patients with unresectable hepatocellular carcinoma (HCC), the first-line therapeutic options are still relatively limited, and treatment outcomes remain poor. We aimed to assess the efficacy and safety of anlotinib combined with toripalimab as first-line therapy for unresectable HCC.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>In this single-arm, multicenter, phase II study (ALTER-H-003), patients with advanced HCC without previous systemic anticancer therapy were recruited. Eligible patients were given anlotinib (12 mg on days 1-14) combined with toripalimab (240 mg on day 1) in a 3-week cycle. The primary endpoint was the objective response rate (ORR) by immune-related Response Evaluation Criteria in Solid Tumours (irRECIST)\/RECIST v1.1 and modified RECIST (mRECIST). Secondary endpoints included disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Between January 2020 and Jul 2021, 31 eligible patients were treated and included in the full analysis set. At data cutoff (January 10, 2023), the ORR was 29.0% (95% CI: 12.1%-46.0%) by irRECIST\/RECIST v1.1, and 32.3% (95% CI: 14.8%-49.7%) by mRECIST criteria, respectively. Confirmed DCR and median DoR by irRECIST\/RECIST v1.1 and mRECIST criteria were 77.4 % (95% CI: 61.8%-93.0%) and not reached (range: 3.0-22.5+ months), respectively. Median PFS was 11.0 months (95% CI: 3.4-18.5 months) and median OS was 18.2 months (95% CI: 15.8-20.5 months). Of the 31 patients assessed for adverse events (AEs), the most common grade \u2265 3 treatment-related AEs were hand-foot syndrome (9.7%, 3\/31), hypertension (9.7%, 3\/31), arthralgia (9.7%, 3\/31), abnormal liver function (6.5%, 2\/31), and decreased neutrophil counts (6.5%, 2\/31).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Anlotinib combined with toripalimab showed promising efficacy and manageable safety in Chinese patients with unresectable HCC in the first-line setting. This combination therapy may offer a potential new therapeutic approach for patients with unresectable HCC.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/oncolo\/oyad169","type":"journal-article","created":{"date-parts":[[2023,6,17]],"date-time":"2023-06-17T18:55:42Z","timestamp":1687028142000},"page":"e1239-e1247","source":"Crossref","is-referenced-by-count":19,"title":["Anlotinib Combined With Toripalimab as First-Line Therapy for Unresectable Hepatocellular Carcinoma: A Prospective, Multicenter, Phase II Study"],"prefix":"10.1093","volume":"28","author":[{"given":"Cheng-Sheng","family":"Zhang","sequence":"first","affiliation":[{"name":"Department of Medical Oncology, The Second Affiliated Hospital of Hainan Medical University , Haikou , People\u2019s Republic of China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zhi-Ming","family":"Zeng","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, The First Affiliated Hospital of 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China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jun-Nv","family":"Xu","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, The Second Affiliated Hospital of Hainan Medical University , Haikou , People\u2019s Republic of China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jie","family":"Zeng","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, The First Affiliated Hospital of Guangxi Medical University , Nanning , People\u2019s Republic of China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jie","family":"Ma","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, The First Affiliated Hospital of Guangxi Medical University , Nanning , People\u2019s Republic of China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hai-Feng","family":"Lin","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, The Second 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