Abstract:Cholangiocarcinoma is an epithelial-origin malignancy for which radical surgical resection is the preferred treatment option. However, most patients are diagnosed at an advanced stage, have already lost the opportunity for surgical removal and are limited to other non-surgical treatments. The standard first-line chemotherapy for advanced cholangiocarcinoma is gemcitabine combined with cisplatin, but this regimen offers a median overall survival of only 11.7 months and is associated with adverse reactions such as neutropenia, thrombocytopenia, fatigue, and anemia. A phase Ⅱ clinical study has demonstrated the potential of paclitaxel (PTX) in improving outcomes for advanced unresectable cholangiocarcinoma, thereby opening up new a application for PTX in the treatment of advanced cholangiocarcinoma. PTX primarily induces tumor cell apoptosis by regulating microtubule depolymerization, showing significant efficacy. However, its poor solubility and high toxicity have limited its clinical application. With the emergence of various novel nanocarriers, the toxicity and solubility of PTX have been greatly improved, and some products have been translated into clinical practice. Studies have confirmed that PTX nanoformulations combined with chemotherapy, targeted therapy, or immune checkpoint inhibitors offer superior efficacy in treating biliary malignancies compared to standard chemotherapy regimens, demonstrating significant clinical value. This paper summarizes the pharmacological properties and application barriers of PTX, the current status of research and development of its nanoformulations, and the progress in its application in biliary malignancies. It also proposes future research directions and potential applications for PTX nanoformulations.