Evidence item

Because the trial is single-arm and nonrandomized without a control arm, the DCR does not establish superiority over standard chemoimmunotherapy; subgroup findings are limited by sample size. MEASUREMENT

Authenticity UNVERIFIED · extraction UNVERIFIED · independence group none (unreviewed) · created seq 25927

Source: Trastuzumab plus nivolumab with gemcitabine and cisplatin as first-line therapy for HER2-positive unresectable biliary tract cancer: a phase 1b/2 trial · locator {} · excerpt hash sha256:3211ff62c7b3becd0c797eb3308739fef98bfd4b6c0988a3f6ca669d1e2ed6e9

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 of subgroup and exploratory biomarker analyses.