{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T14:33:25Z","timestamp":1790087605881,"version":"4.0.1"},"reference-count":25,"publisher":"Wiley","issue":"21","license":[{"start":{"date-parts":[[2021,8,6]],"date-time":"2021-08-06T00:00:00Z","timestamp":1628208000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["acsjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer"],"published-print":{"date-parts":[[2021,11]]},"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>Several clinical studies of vascular endothelial growth factor\/vascular endothelial growth factor receptor (VEGF\/VEGFR) therapy as a second\u2010line treatment for biliary tract cancer (BTC) have shown modest efficacy. In this study, surufatinib was evaluated as a second\u2010line VEGFR therapy in patients with BTC.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This was a single\u2010arm, multicenter, open\u2010label phase 2 study conducted in China. The study enrolled eligible patients with BTC, who had received surufatinib monotherapy as second\u2010line treatment, at a dose of 300 mg, once daily, in 28\u2010day cycles. Tumor assessments were performed every 8 weeks (\u00b17 days) according to the Response Evaluation Criteria in Solid Tumors version 1.1.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>As of November 30, 2018, 39 patients with BTC, including 29 (74.4%) with intrahepatic cholangiocarcinoma, 5 (12.8%) with extrahepatic cholangiocarcinoma, and 5 (12.8%) with gallbladder cancer, were enrolled and treated with surufatinib. The 16\u2010week progression\u2010free survival rate was 46.33% (95% CI, 24.38\u201065.73), with median progression\u2010free survival of 3.7 months and median overall survival of 6.9 months. In addition, results from subgroup and post hoc analyses revealed that patients with the proper tumor locations or appropriate levels of serum biomarkers might receive greater clinical benefits. The top 3 treatment\u2010related adverse events with severity of grade \u22653 included blood bilirubin increased (20.5%), hypertension (17.9%), and proteinuria (12.8%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>When applied in the treatment of patients with BTC, surufatinib monotherapy has offered moderate clinical efficacy and shown expected tolerability and safety profiles.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cncr.33803","type":"journal-article","created":{"date-parts":[[2021,8,6]],"date-time":"2021-08-06T08:11:12Z","timestamp":1628237472000},"page":"3975-3984","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":29,"title":["A single\u2010arm, multicenter, open\u2010label phase 2 trial of surufatinib in patients with unresectable or metastatic biliary tract cancer"],"prefix":"10.1002","volume":"127","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4467-6021","authenticated-orcid":false,"given":"Jianming","family":"Xu","sequence":"first","affiliation":[{"name":"Department of Gastrointestinal Oncology, The Fifth Medical Center General Hospital of the People's Liberation Army Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuxian","family":"Bai","sequence":"additional","affiliation":[{"name":"Department of Oncology The Affiliated Tumor Hospital of Harbin Medical University Harbin China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3761-7058","authenticated-orcid":false,"given":"Huichuan","family":"Sun","sequence":"additional","affiliation":[{"name":"Department of Liver Surgery and Liver Transplantation Zhongshan Hospital, Fudan University Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1333-9145","authenticated-orcid":false,"given":"Chunmei","family":"Bai","sequence":"additional","affiliation":[{"name":"Department of Oncology Chinese Academy of Medical Science &amp; Peking Union Medical College Hospital Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ru","family":"Jia","sequence":"additional","affiliation":[{"name":"Department of Gastrointestinal Oncology, The Fifth Medical Center General Hospital of the People's Liberation Army Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yi","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Gastrointestinal Oncology, The Fifth Medical Center General Hospital of the People's Liberation Army Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wenjie","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Oncology The Affiliated Tumor Hospital of Harbin Medical University Harbin China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lei","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Oncology The Affiliated Tumor Hospital of Harbin Medical University Harbin China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cheng","family":"Huang","sequence":"additional","affiliation":[{"name":"Department of Liver Surgery and Liver Transplantation Zhongshan Hospital, Fudan University Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mei","family":"Guan","sequence":"additional","affiliation":[{"name":"Department of Oncology Chinese Academy of Medical Science &amp; 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