{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T14:35:34Z","timestamp":1786977334359,"version":"build-2736575974"},"reference-count":50,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2026,3,27]],"date-time":"2026-03-27T00:00:00Z","timestamp":1774569600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,3,27]],"date-time":"2026-03-27T00:00:00Z","timestamp":1774569600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/501100012226","name":"Fundamental Research Funds for the Central Universities","doi-asserted-by":"publisher","award":["226\u20102025\u201000172"],"award-info":[{"award-number":["226\u20102025\u201000172"]}],"id":[{"id":"10.13039\/501100012226","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Medicine"],"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Biliary tract cancer (BTC) is an aggressive malignancy characterized by a high recurrence rate and poor postoperative prognosis, despite advances in adjuvant therapy. This phase II study evaluated the efficacy and safety of a novel adjuvant regimen combining envafolimab, lenvatinib, and capecitabine in patients with BTC at high risk of recurrence following R0 resection.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      This single\u2010center, open\u2010label, single\u2010arm phase II trial enrolled patients with high\u2010risk recurrence factors after curative resection. Patients received envafolimab (400\u2009mg subcutaneously once every 3\u2009weeks), Lenvatinib (8\u2009mg orally once daily), and capecitabine (1000\u2009mg\/m\n                      <jats:sup>2<\/jats:sup>\n                      orally twice daily, 2\u2009weeks on\/1\u2009week off, continued without cycle limitation). The primary endpoint was disease\u2010free survival (DFS); secondary endpoints included overall survival (OS) and safety.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>28 of 30 screened patients were included in the final analysis. The median DFS was 15.63\u2009months, and the 1\u2010year DFS rate was 68.3%. Median OS was not reached but 1\u2010year OS was 91.4%. Treatment\u2010related adverse events (TRAEs) occurred in 17 patients, with grade 3\/4 TRAEs observed in eight patients. No treatment\u2010related deaths were reported. Exploratory analysis suggested that baseline CA19\u20109 levels were significantly associated with early recurrence.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The adjuvant combination of envafolimab, lenvatinib, and capecitabine demonstrates promising efficacy and a manageable safety profile in high\u2010risk BTC patients after R0 resection. However, these findings still require validation in larger, multicenter, randomized controlled trials.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/cam4.71756","type":"journal-article","created":{"date-parts":[[2026,3,27]],"date-time":"2026-03-27T11:02:26Z","timestamp":1774609346000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Efficacy and Safety of Envafolimab Combined With Capecitabine and Lenvatinib as Postoperative Adjuvant Therapy in Resected Biliary Tract Cancer With High\u2010Risk Recurrence Factors: A Phase\n                    <scp>II<\/scp>\n                    Single\u2010Center Prospective Study"],"prefix":"10.1002","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0009-0005-7813-2710","authenticated-orcid":false,"given":"Yitong","family":"Tian","sequence":"first","affiliation":[{"name":"Department of General Surgery, Sir Run\u2010Run Shaw Hospital Zhejiang University  Hangzhou 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