Gemcitabine and Cisplatin Plus Polymeric Micellar Paclitaxel and Survival in Advanced Biliary Tract Cancer: A Randomized Clinical Trial.

ABSTRACT:

Importance

Limited prospective data exist on the role of adding taxane to standard chemotherapy in the first-line treatment of advanced biliary tract cancers, especially in the Asian population, where biliary tract cancers are most prevalent.

Objective

To assess the efficacy and safety of polyethoxylated castor oil-free polymeric micelle formulation of paclitaxel (hereafter, polymeric micellar paclitaxel), in combination with gemcitabine and cisplatin in patients with untreated advanced biliary tract cancers.

Design, setting, and participants

This open-label, phase 3 randomized clinical trial was conducted across 7 centers in South Korea from September 1, 2019, to October 31, 2022. Patients were eligible if they had previously untreated, locally advanced unresectable,

SUBMITTER: Jeong H 

PROVIDER: S-EPMC12489695 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature