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
Abstract
BACKGROUND

Biliary tract cancers (BTCs) are a heterogeneous group of tumors with high malignancy, poor prognosis, and limited treatment options.

AIM

To explore the efficacy and safety of nab-paclitaxel plus capecitabine as first-line treatment for advanced and metastatic BTCs.

METHODS

This open-label, non-randomized, double-center, phase II clinical trial recruited systemic therapy-naive patients with unresectable or metastatic BTCs between April 2019 and June 2022 at Beijing Cancer Hospital and the First Hospital of China Medical University. Eligible patients were administered nab-paclitaxel (150 mg/m2, day 1) and capecitabine (2000 mg/m2, twice daily, days 1-7) in 14-day cycles until experiencing intolerable toxicity or disease progression. The primary outcome was the objective response rate (ORR). The secondary outcomes included the disease control rate (DCR), overall survival (OS), progression-free survival (PFS), and safety.

RESULTS

A total of 44 patients successfully completed the trial, with a median age of 64.00 years (interquartile range, 35.00-76.00), and 26 (59.09%) were females. Tumor response assessment was impeded for one patient due to premature demise from tumor hemorrhage. Among the remaining 43 patients undergoing at least one imaging assessment, the ORR was 23.26% [95% confidence interval (CI): 11.80%-38.60%], and the DCR was 69.77% (95%CI: 53.90%-82.80%). The median OS was 14.1 months (95%CI: 8.3-19.9), and the median PFS was 4.4 months (95%CI: 2.5-6.3). A total of 41 patients (93.18%) experienced at least one adverse event (AE), with 10 patients (22.73%) encountering grade ≥ 3 AEs, and the most frequent AEs of any grade were alopecia (79.50%), leukopenia (54.55%), neutropenia (52.27%), and liver dysfunction (40.91%), and no treatment-related deaths were documented.

CONCLUSION

Nab-paclitaxel plus capecitabine may be an effective and safe first-line treatment strategy for patients with advanced or metastatic BTCs.

Keywords: Nab-paclitaxel, Capecitabine, Biliary tract cancer, Objective response rate, Phase II clinical trial

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.