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Histologically confirmed advanced BTC patients with documented disease progression after first\u2010line chemotherapy were enrolled. Subjects received nab\u2010paclitaxel 125\u2009mg\/m<jats:sup>2<\/jats:sup> on days 1 and 8 plus sintilimab 200\u2009mg on day 1, administered every 3\u2009weeks. The primary end point was the objective response rate (ORR). The secondary end points were progression\u2010free survival (PFS), overall survival (OS), and adverse reactions. Simultaneously, next\u2010generation sequencing, programmed cell death ligand 1 immunohistochemistry and multiplex immunofluorescence of tumor\u2010infiltrating lymphocytes were applied to explore potential biomarkers. Twenty\u2010six subjects were consecutively enrolled. The ORR was 26.9% (7\/26), including two complete responses and five partial responses, which met the primary end point. The disease control rate was 61.5% (16\/26). The median PFS was 169\u2009days (about 5.6\u2009months, 95% confidence interval [CI] 60\u2013278\u2009days). The median OS was 442\u2009days (about 14.7\u2009months, 95% CI 298\u2013586\u2009days). Grade 3 treatment\u2010related adverse events (TRAEs) were mainly anemia (27%), leukopenia (23%), neutropenia (19%), and peripheral sensory neuropathy (8%). No grade 4 or 5 TRAEs occurred. Biomarker analysis suggested that positive PD\u2010L1 and high proportions of CD8<jats:sup>+<\/jats:sup> T\u2010cell infiltration were correlated with improved clinical outcome. Nab\u2010paclitaxel plus sintilimab is a potentially effective and tolerable second\u2010line regimen for advanced BTC that deserves to be studied in large\u2010scale trials. PD\u2010L1 status and CD8<jats:sup>+<\/jats:sup> T cell infiltration might be promising biomarkers for efficacy prediction.<\/jats:p>","DOI":"10.1111\/cas.16179","type":"journal-article","created":{"date-parts":[[2024,4,19]],"date-time":"2024-04-19T06:14:11Z","timestamp":1713507251000},"page":"2371-2383","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Efficacy and biomarker analysis of second\u2010line nab\u2010paclitaxel plus sintilimab in patients with advanced biliary tract cancer"],"prefix":"10.1111","volume":"115","author":[{"given":"Xiaofen","family":"Li","sequence":"first","affiliation":[{"name":"Department of Medical Oncology, Cancer Center, West China Hospital Sichuan University  Chengdu China"},{"name":"Division of Abdominal Tumor Multimodality Treatment, Cancer Center, West China Hospital Sichuan University  Chengdu 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