Treatment with gemcitabine/cisplatin and durvalumab for advanced biliary tract cancer - real-world data from a multicenter German patient population

Sep 24, 2026

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Biliary tract cancers comprise a heterogeneous malignancy group with poor prognosis, previously treated in the first-line palliative setting by gemcitabine/cisplatin chemotherapy. This study evaluates retrospective real-world outcomes for advanced BTC patients receiving gemcitabine/cisplatin plus durvalumab in German university hospitals and oncology practices between July 2022 and March 2024. Among 90 patients, median overall survival was 16 months and median progression-free survival was 5 months, with an ORR of 11.1% and DCR of 41.1%.

LanguageEnglish

CategoryHealthcare

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Abstract

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Journal of Cancer Research and Clinical Oncology (2025) 151:191 [https://doi.org/10.1007/s00432-025-06239-1](https://doi.org/10.1007/s00432-025-06239-1) RESEARCH Treatment with gemcitabine/cisplatin and durvalumab for advanced biliary tract cancer – real-world data from a multicenter German patient population Florian Gerhardt1 · Christian Müller2 · MarinoVenerito2 · Jack Chater3 · Raphael Mohr4 · Mara Egerer4 · Udo Lindig5 · Aaron Schindler1 · Sebastian Ebel6 · Janett Fischer1 · Maik Schwarz7 · Sonja Gehring8 · Thomas Berg1 · Florian van Bömmel1 Received: 23 February 2025 / Accepted: 3 June 2025 / Published online: 18 June 2025 © The Author(s) 2025 Abstract Background Biliary tract cancers (BTCs) are a heterogeneous group of malignant cancers with an overall poor prognosis. For more than a decade, the standard palliative first-line therapy was cytotoxic chemotherapy with gemcitabine/cisplatin. The results of the TOPAZ-1 and KEYNOTE-966 trials have now introduced immune checkpoint inhibitors (ICIs) into firstline therapy. Methods Between July 2022 and March 2024, we retrospectively analyzed patients with advanced BTC who were treated with gemcitabine/cisplatin and durvalumab (GCD) at collaborating German university hospitals, tertiary hospitals, and outpatient oncology practices. Results A total of 90 patients were enrolled. The median overall survival (mOS) was 16 months, and the median progression-free survival (mPFS) was 5 months. The overall response rate (ORR) was 11.1%, and the disease control rate (DCR) was 41.1%. A perihilar primary tumor was significantly associated with better mPFS, while age group between 70 and 75 years and performance status of ECOG 2 at treatment initiation were significantly associated with poorer mOS. Adverse events (AEs) occurred in a total of 64% of patients. The most common grade 1 and grade 2 AEs included anemia (23%), thrombocytopenia (16%), neutropenia (10%), nausea (14%), and fatigue (16%) . Grade 3 and grade 4 AEs included anemia (10%), thrombocytopenia (5%), and neutropenia (11%) . Only one case of immune-mediated hypothyroidism (imAE) was documented. Conclusion Our real-world data support previously reported findings and further validate ICI based therapy as the standard of care for patients with advanced BTCs. Keywords Cholangiocarcinoma · Biliary tract cancer · Liver cancer · Immune checkpoint inhibitor · Real-world data 􀀍 Florian van Bömmel [florian.vanboemmel@medizin.uni-leipzig.de](florian.vanboemmel@medizin.uni-leipzig.de) 1 Division of Hepatology, Department of Medicine II, Leipzig University Medical Center, Leipzig, Germany 2 Department of Gastroenterology, Hepatology and Infectious Diseases, Otto von Guericke University Hospital, Magdeburg, Germany 3 Medical Clinic III, Klinikum Chemnitz, Chemnitz, Germany 4 Department of Hepatology and Gastroenterology, Charité University Medicine Berlin, Berlin, Germany 5 Medical Clinic II, University Hospital Jena, Jena, Germany 6 Department of Diagnostic and Interventional Radiology, Leipzig University Medical Center, Leipzig, Germany 7 MVZ Schöneck, Schöneck, Germany 8 Department of Gastroenterology, University Hospital Marburg, Marburg, Germany Introduction Biliary tract cancer (BTC), including intrahepatic cholangiocarcinoma (iCCA), extrahepatic cholangiocarcinoma (eCCA, perihilar and distal), gallbladder cancer, and ampullary cancer, are a heterogeneous group of rare malignancies originating from the biliary tract epithelium (Valle et al. 2021) . The heterogeneity extends not only to anatomical localization but also notably to molecular and biological characteristics (Valle et al. 2017; Kendre et al. 2023) . BTCs are often diagnosed in advanced stages, and the prognosis is poor (Banales et al. 2020) . The incidence and mortality of intrahepatic cholangiocarcinoma (iCCA) have tended to increase over the past years, while the mortality for extrahepatic cholangiocarcinoma (eCCA) has decreased

FAQs

What is the study’s purpose regarding advanced biliary tract cancer treatment?

The study assesses real-world effectiveness of combining gemcitabine/cisplatin with durvalumab for patients with advanced biliary tract cancer.

What outcomes were observed for overall survival, progression-free survival, and response rates?

In the enrolled 90 patients, median overall survival was 16 months, median progression-free survival was 5 months, with an overall response rate of 11.1% and a disease control rate of 41.1%.

Which patient and tumor factors were associated with survival differences?

A perihilar primary tumor was associated with better mPFS, while age 70–75 years and ECOG performance status 2 at treatment initiation were associated with poorer mOS.

Sep 24, 2026

Uploaded by Stanley