{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T18:48:02Z","timestamp":1792090082654,"version":"4.4.0"},"reference-count":16,"publisher":"S. Karger AG","issue":"5","license":[{"start":{"date-parts":[[2022,1,1]],"date-time":"2022-01-01T00:00:00Z","timestamp":1640995200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2022,1,1]],"date-time":"2022-01-01T00:00:00Z","timestamp":1640995200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Liver Cancer"],"published-print":{"date-parts":[[2022]]},"abstract":"<b><i>Introduction:<\/i><\/b> This investigator-initiated clinical trial aims to study the efficacy and safety of administering selective internal radiation therapy with resin yttrium-90 microspheres (SIRT) followed by standard chemotherapy in unresectable intrahepatic cholangiocarcinoma (ICC). <b><i>Methods:<\/i><\/b> A phase 2 single-arm multicenter study was conducted in patients with unresectable ICC (NCT02167711). SIRT was administered at dose of 120 Gy targeted at tumor followed by commencement of gemcitabine 1,000 mg\/m<sup>2<\/sup> and cisplatin 25 mg\/m<sup>2<\/sup> on days one and eight of a 21-day cycle. The primary endpoint was overall survival (OS), and the secondary endpoints include progression-free survival (PFS), response rate according to Response Evaluation Criteria in solid tumors 1.1, toxicity, and time from SIRT to commencement of chemotherapy. <b><i>Results:<\/i><\/b> Total 31 patients were screened and twenty-four were recruited. All patients completed SIRT and 16 of them underwent subsequent chemotherapy. The median cycle of chemotherapy was 5 (range: 1\u20138). The median OS was 13.6 months (95% CI: 5.4\u201321.6) for the intent-to-treat population. Among 16 patients undergoing chemotherapy, the median OS was 21.6 months (95% CI: 7.3\u201325.2) and the median PFS was 9 months (95% CI: 3.2\u201313.1). The response rate was 25% (95% CI: 3.8\u201346.2%), and the disease control rate was 75% (95% CI: 53.8\u201396.2%). No new safety signal was observed, with fewer than 10% of patients suffering from grade 3 or higher treatment-related adverse events. The median time from SIRT to chemotherapy was 29 (range: 7\u201342) days. Eight patients could not receive chemotherapy due to rapid progressive disease (<i>n<\/i> = 4), underlying treatment unrelated comorbidities (<i>n<\/i> = 2), and withdrawal of consent due to personal reasons (<i>n<\/i> = 2). <b><i>Conclusions:<\/i><\/b> Treatment of SIRT followed by standard gemcitabine and cisplatin chemotherapy is feasible and effective for unresectable ICC. Further studies are required to study the optimal sequence of SIRT and chemotherapy. <\/jats:p>","DOI":"10.1159\/000525489","type":"journal-article","created":{"date-parts":[[2022,6,15]],"date-time":"2022-06-15T17:19:03Z","timestamp":1655313543000},"page":"451-459","source":"Crossref","is-referenced-by-count":25,"title":["Selective Internal Radiation Therapy with Yttrium-90 Resin Microspheres Followed by Gemcitabine plus Cisplatin for Unresectable Intrahepatic Cholangiocarcinoma: A Phase 2 Single-Arm Multicenter Clinical Trial"],"prefix":"10.1159","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8998-5480","authenticated-orcid":false,"given":"Stephen Lam","family":"Chan","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chanisa","family":"Chotipanich","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8925-3922","authenticated-orcid":false,"given":"Su Pin","family":"Choo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Su Wen","family":"Kwang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0566-3212","authenticated-orcid":false,"given":"Frankie","family":"Mo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2362-2788","authenticated-orcid":false,"given":"Akeanong","family":"Worakitsitisatorn","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Tai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9423-1368","authenticated-orcid":false,"given":"Raghav","family":"Sundar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David Chee Eng","family":"Ng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kelvin Siu Hoong","family":"Loke","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0251-0253","authenticated-orcid":false,"given":"Leung","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3679-6368","authenticated-orcid":false,"given":"Kelvin Kwok Chai","family":"Ng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4404-3777","authenticated-orcid":false,"given":"Yong Wei","family":"Peng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simon Chun-Ho","family":"Yu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"127","published-online":{"date-parts":[[2022,6,15]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","DOI":"10.7759\/cureus.3962"},{"key":"ref2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(21)00153-7"},{"key":"ref3","doi-asserted-by":"publisher","DOI":"10.1038\/nrgastro.2016.51"},{"key":"ref4","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0908721"},{"key":"ref5","doi-asserted-by":"publisher","DOI":"10.1016\/j.ctrv.2021.102258"},{"key":"ref6","doi-asserted-by":"publisher","DOI":"10.1097\/MEG.0b013e3283502241"},{"key":"ref7","doi-asserted-by":"publisher","DOI":"10.1007\/s00270-011-0142-x"},{"key":"ref8","doi-asserted-by":"publisher","DOI":"10.1245\/s10434-009-0777-x"},{"key":"ref9","doi-asserted-by":"publisher","DOI":"10.1007\/s00270-012-0463-4"},{"key":"ref10","doi-asserted-by":"publisher","DOI":"10.1111\/hpb.12441"},{"key":"ref11","doi-asserted-by":"publisher","DOI":"10.1001\/jamaoncol.2019.3702"},{"key":"ref12","doi-asserted-by":"publisher","DOI":"10.1038\/bjc.1994.436"},{"key":"ref13","doi-asserted-by":"publisher","DOI":"10.1007\/s00259-019-04340-5"},{"key":"ref14","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.30237"},{"key":"ref15","doi-asserted-by":"publisher","DOI":"10.1200\/PO.18.00414"},{"key":"ref16","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2020.03.007"}],"container-title":["Liver Cancer"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.karger.com\/Article\/Pdf\/525489","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.karger.com\/Article\/Pdf\/525489","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,23]],"date-time":"2025-04-23T15:05:28Z","timestamp":1745420728000},"score":1,"resource":{"primary":{"URL":"https:\/\/karger.com\/article\/doi\/10.1159\/000525489"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022]]},"references-count":16,"journal-issue":{"issue":"5","published-online":{"date-parts":[[2022,9,2]]},"published-print":{"date-parts":[[2022,9,6]]}},"URL":"https:\/\/doi.org\/10.1159\/000525489","archive":["Portico"],"relation":{},"ISSN":["2235-1795","1664-5553"],"issn-type":[{"value":"2235-1795","type":"print"},{"value":"1664-5553","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022]]}}}