{"id":5951,"date":"2026-10-08T03:48:31","date_gmt":"2026-10-07T18:48:31","guid":{"rendered":"https:\/\/www.lunit.io\/en\/?post_type=publication&p=5951"},"modified":"2026-10-08T03:48:31","modified_gmt":"2026-10-07T18:48:31","slug":"trastuzumab-plus-nivolumab-with-gemcitabine-and-cisplatin-as-first-line-therapy-for-her2-positive-unresectable-biliary-tract-cancer-a-phase-1b-2-trial","status":"publish","type":"publication","link":"https:\/\/www.lunit.io\/en\/publication\/trastuzumab-plus-nivolumab-with-gemcitabine-and-cisplatin-as-first-line-therapy-for-her2-positive-unresectable-biliary-tract-cancer-a-phase-1b-2-trial\/","title":{"rendered":"Trastuzumab plus nivolumab with gemcitabine and cisplatin as first-line therapy for HER2-positive unresectable biliary tract cancer: a phase 1b\/2 trial"},"content":{"rendered":"

Abstract<\/h2>\n
\n

Biliary tract cancers (BTCs) are associated with poor outcomes despite recent incorporation of immune checkpoint inhibitors into first-line chemotherapy. Human epidermal growth factor receptor 2 (HER2) overexpression or amplification defines a therapeutically targetable subset of BTC but its integration into first-line chemoimmunotherapy has not been prospectively evaluated. This multi-institutional, open-label, phase 1b\/2 HERBOT study (KCSG-HB23-05) aimed to evaluate first-line HER2-targeted quadruplet regimen consisting of trastuzumab, nivolumab, gemcitabine and cisplatin in participants with HER2-positive advanced BTC. Here the primary endpoint was met with an objective response rate of 55% (95% confidence interval (CI) 38.5\u201370.7; one complete response and 21 partial responses among 40 participants) and a disease control rate of 95% (95% CI 83.5\u201399.4); the median duration of response was 12.6\u2009months (95% CI 5.7\u2013not reached). With a median follow-up of 17.0\u2009months, the median progression-free survival was 10.6\u2009months (95% CI 7.8\u201317.4) and median overall survival was not reached. Two participants (5.0%) underwent curative-intent conversion surgery. Common grade \u22653 treatment-related adverse events included neutropenia (57.5%), anemia (30.0%) and thrombocytopenia (22.5%). Preplanned artificial-intelligence-powered whole-slide image analyses suggested that tumors with higher proportions of HER2 3+ cells were associated with greater clinical benefit. These findings suggest that upfront HER2-targeted therapeutic intensification in BTC may represent a promising direction for future first-line treatment strategies, with relevance to ongoing phase 3 studies. ClinicalTrials.gov identifier: NCT05749900<\/a>.<\/p>\n<\/div>\n

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