Clinical Trials Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Aug 14, 2024; 30(30): 3564-3573
Published online Aug 14, 2024. doi: 10.3748/wjg.v30.i30.3564
Nab-paclitaxel plus capecitabine as first-line treatment for advanced biliary tract cancers: An open-label, non-randomized, phase II clinical trial
Ling-Xiao Xu, Jia-Jia Yuan, Ran Xue, Jun Zhou
Ling-Xiao Xu, Jia-Jia Yuan, Ran Xue, Jun Zhou, Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing 100142, China
Author contributions: Zhou J and Xu LX carried out the studies, participated in collecting data, and drafted the manuscript; Xu LX and Yuan JJ performed the statistical analysis and participated in its design; Xu LX and Xue R participated in acquisition, analysis, or interpretation of data and draft the manuscript. All authors read and approved the final manuscript.
Institutional review board statement: This study was reviewed and approved by the Ethics Committee of Peking University Cancer Hospital and Institute (approval number: 2018YJZ70-ZY02).
Clinical trial registration statement: This study has been registered at https://www.chictr.org.cn (ID: ChiCTR1900025004).
Informed consent statement: All the individuals who participated in this study provided their written informed consent prior to study enrolment.
Conflict-of-interest statement: The authors declare that they have no competing interests.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Jun Zhou, MD, Chief Doctor, Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, No. 52 Fucheng Road, Haidian District, Beijing 100142, China. joelbmu@126.com
Received: June 5, 2024
Revised: July 8, 2024
Accepted: July 16, 2024
Published online: August 14, 2024
Processing time: 65 Days and 2 Hours
Core Tip

Core Tip: Our study investigates the efficacy and safety of nab-paclitaxel plus capecitabine as first-line treatment for advanced and metastatic biliary tract cancers (BTCs). Through an open-label, non-randomized, double-center, phase II clinical trial, we enrolled systemic therapy-naive patients. Our findings demonstrate that nab-paclitaxel plus capecitabine demonstrates both acceptable efficacy and safety in patients with advanced and metastatic BTCs. This regimen shows promise as a potential novel treatment option for this patient population and warrants further validation in future trials.