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Trastuzumab plus nivolumab with gemcitabine and cisplatin as first-line therapy for HER2-positive unresectable biliary tract cancer: a phase 1b/2 trial PRIMARY_TEXT retrieval pending
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| Locator | Excerpt |
|---|---|
QUOTE {} | Between 12 May 2023 and 3 December 2024, 49 participants with known HER2-positive BTC were screened, with 40 enrolled across 12 sites in South Korea... All included participants were treatment-naive for advanced or metastatic diseases. T... |
QUOTE {} | The ORR was 55% (22/40; 95% CI 38.5–70.7), exceeding the prespecified Simon two-stage criterion... and the DCR was 95.0% (95% CI 83.5–99.4). |
QUOTE {} | This study had some limitations. Firstly, the single-arm, nonrandomized design without a control arm limits definitive comparison to the current standard of care of chemoimmunotherapy alone... the modest sample size limits the robustness... |