What type of study is this?

This is a Meta-Analysis study (also classified as: Systematic Review).

What question did this study set out to answer?

This research evaluates the impact of adding immunotherapy to gemcitabine and cisplatin in treating advanced cholangiocarcinoma.

January 14, 2026

First-line immunotherapy plus gemcitabine–cisplatin versus chemotherapy alone in advanced cholangiocarcinoma: A meta-analysis.

Key Points

This research evaluates the impact of adding immunotherapy to gemcitabine and cisplatin in treating advanced cholangiocarcinoma.
Conducted a systematic review and meta-analysis of published clinical trials.
Included studies on gemcitabine-cisplatin plus either durvalumab or pembrolizumab targeting unresectable or metastatic cholangiocarcinoma.
Analyzed outcomes like overall survival and progression-free survival, and assessed adverse events.
Combination of immunotherapy with gemcitabine-cisplatin significantly improved overall survival compared to gemcitabine-cisplatin alone.
Median overall survival for immunotherapy plus gemcitabine-cisplatin was 14.1 months, with a hazard ratio of 0.6.
Grade 3-4 adverse events were rare, particularly with therapies involving pembrolizumab.

Abstract

573 Background: Cholangiocarcinoma (CAA) is a rare but highly aggressive malignancy arising from the bile duct epithelium, with rapidly increasing incidence and mortality in recent years. Surgery remains the only curative treatment, while radiotherapy and chemotherapy play important roles in controlling disease progression and improving survival. The addition of immunotherapy (IO) to gemcitabine plus cisplatin (GemCis) has been shown in phase 3 randomized clinical trials to significantly improve overall survival (OS). This study aims to evaluate the efficacy and safety of combining IO with GemCis versus GemCis in unresectable and metastatic CCA through a systematic review and meta-analysis. Methods: For this systemic review and meta-analysis, we searched PubMed, Embase, Scopus, Google Scholar for English-language studies published between 2009 and 2025. Eligible studies included randomized clinical trials and cohort studies evaluating GemCis, durvalumab plus GemCis, pembrolizumab plus GemCis as first-line treatment for unresectable or metastatic CCA. The primary outcome was OS, and the secondary outcomes included progression-free survival (PFS) and adverse events (AEs) based on Common Terminology Criteria of Adverse Events (CTCAE). For studies presenting Kaplan-Meier curves, individual patient data (IPD) tool was used to reconstruct the data for outcome calculations. Results: A total of 3,703 patients with Unresectable or metastatic CCA from TPAZ-1, KEYNOTE-966, ABC-1/2 and six additional cohort studies were included. Of these,1,737 received GemCis, 1.433 GemCis plus durvalumab, and 533 GemCis plus pembrolizumab. The meta-analysis demonstrated that the GemCis-durvalumab group achieved superior outcomes, with a median OS of 14.1 months (HR = 0.6; 95% CI = 0.55–0.66; p value < 0.001) and a median PFS of 7.3 months (HR = 0.75, 95% CI = 0.69–0.82, p value = 0.001). Overall, grade 3-4 toxicities were uncommon across treatment arms, with thrombocytopenia occurring more frequently in the GemCis plus pembrolizumab (p = 0.0002); other severe adverse events were similar between groups. Conclusions: The addition of IO to GemCis significantly improves survival outcomes in patients with unresectable or metastatic CCA, with GemCis plus durvalumab demonstrating the most substantial benefit. All treatment regimens were generally tolerated, with few grades 3-4 adverse events. These findings support the incorporation of IO into first-line therapy for advanced CCA.

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