Safety and efficacy of PD-1/PD-L1 inhibitors combined with albumin-bound paclitaxel and fluorouracil-based agents as second-line therapy in biliary tract cancers

Sep 22, 2026

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Biliary tract cancers remain highly aggressive with limited second-line options after gemcitabine plus cisplatin failure. A retrospective real-world cohort evaluated second-line PD-1/PD-L1 inhibitors combined with albumin-bound paclitaxel and fluorouracil-based agents (capecitabine or S-1) at the Second Affiliated Hospital of Nanchang University. Tumor response used RECIST v1.1; adverse events were graded by CTCAE v5.0. Thirty-six advanced BTC patients were included; ORR was 11.1%, DCR 63.9%, median PFS 6.8 months and OS 10.8 months, with manageable toxicity and no treatment-related deaths.

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Wang et al. World Journal of Surgical Oncology (2026) 24:288 [https://doi.org/10.1186/s12957-026-04393-5](https://doi.org/10.1186/s12957-026-04393-5) World Journal of Surgical Oncology RESEARCH Open Access Safety and efficacy of PD-1/PD-L1 inhibitors combined with albumin-bound paclitaxeland fluorouracil-based agents as second-line therapy in biliary tract cancers Xiao Wang1, Ying Zha2, Pengen Li1, Shumin Fu1, Lin Xu3, Weimin Jiang1, Jianbing Wu1 andYe Mao1* Abstract Background Biliary tract cancers (BTCs) are a group of highly aggressive malignancies with limited therapeutic options. Gemcitabine plus cisplatin (GemCis) remains the standard first-line regimen; however, the efficacy of currently recommended second-line therapies remains unsatisfactory. Immune checkpoint inhibitors (ICIs) targeting programmed cell death protein 1 or its ligand (PD-1/PD-L1) have demonstrated antitumor activity in a subset of patients with BTC, while albumin-bound paclitaxel (nab-paclitaxel) has shown efficacy across multiple solid tumors. This study aimed to evaluate the real-world safety and efficacy of a second-line combination regimen comprising PD-1/PD-L1 inhibitors, nab-paclitaxel, and fluorouracil-based agents (capecitabine or S-1) in patients with advanced BTCs. Methods This retrospective study included patients with advanced BTCs who received second-line therapy with a combination of PD-1/PD-L1 inhibitors, nab-paclitaxel, and fluorouracil-based agents (capecitabine or S-1) at the Second Affiliated Hospital of Nanchang University between January 2019 and May 2025. Tumor response was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1. 1, and treatment-related adverse events (TRAEs) were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The primary endpoint was progression-free survival (PFS); secondary endpoints included overall survival (OS), objective response rate (ORR), and TRAEs. Results A total of 36 patients were enrolled, including 17 (47 . 2%) with gallbladder cancer, 17 (47 . 2%) with intrahepatic cholangiocarcinoma, and 2 (5 . 6%) with extrahepatic cholangiocarcinoma. According to RECIST version 1. 1, no complete responses (CR) were observed; four patients (11 . 1%) achieved a partial response (PR), 19 (52 . 8%) had stable disease (SD), and 13 (36 . 1%) experienced progressive disease (PD), yielding an ORR of 11. 1% and a disease control rate (DCR) of 63 . 9% . The median progression-free survival (PFS) was 6.8 months (95% confidence interval [CI]: 4.2–10. 2), and the median overall survival (OS) was 10.8 months (95% CI: 7.2–16. 2) . No significant differences in PFS (6 .8 vs. 7.9 months, P = 0 . 55) or OS (11 .1 vs. 10.8 months, P = 0 . 68) were observed between patients who had received prior immunotherapy and those who had not. The most common grade 3–4 TRAEs were chemotherapy-related *Correspondence: Ye Mao rayooocat1 [11@163.com](11@163.com) Full list of author information is available at the end of the article © The Author(s) 2026. Open Access This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License, which permits any non-commercial use, sharing, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if you modified the licensed material. You do not have permission under this licence to share adapted material derived from this article or parts of it. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly fro

FAQs

What treatment combination was evaluated for advanced biliary tract cancers?

The study assessed second-line therapy combining PD-1/PD-L1 inhibitors with albumin-bound paclitaxel and fluorouracil-based agents (capecitabine or S-1).

How were tumor response and adverse events measured?

Tumor response followed RECIST version 1.1, and treatment-related adverse events were graded using CTCAE version 5.0.

What were the main efficacy outcomes reported?

No complete responses were observed; partial response occurred in 11.1%, and stable disease accounted for 52.8%. Median progression-free survival was 6.8 months and median overall survival was 10.8 months.

Sep 22, 2026

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