STUDY PROTOCOL article
Front. Pharmacol.
Sec. Gastrointestinal and Hepatic Pharmacology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1610575
Brucea javanica Oil Emulsion plus Supportive Care for Refractory Advanced Colorectal Cancer: A Pilot RCT Protocol
Provisionally accepted
- 1Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China
- 2Beijing University of Chinese Medicine, Beijing, Beijing Municipality, China
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Background:Colorectal cancer (CRC) is a significant contributor to global mortality.However, the existing therapeutic approaches often fall short of achieving favorable outcomes especially in metastatic CRC. Brucea javanica Oil Emulsion Injection (BJOEI) as adjuvant therapy also showed superiority for cancer treatment in clinical practice. This trial aims to to gather preliminary data to inform a phase III clinical trial evaluating the efficacy and safety of BJOEI in combination with best supportive care (BSC) for patients with advanced colorectal cancer who are refractory to all existing therapies..The study is designed as a multicenter, randomized, and controlled clinical trial. 60 eligible participants will be randomly assigned to the experimental or control group in a ratio of 1:1. The experimental group will receive BJOEI and BSC, while the control group will undergo BSC. The treatment will cease upon disease progression or when toxicity becomes intolerable. Follow-up assessments will be scheduled every two months, continuing until the patient dies, is lost to follow-up, or reaches 12 months post-randomization. The main outcome measured will be progression-free survival (PFS). Additional outcomes to be evaluated are clinical symptoms, quality of life, and overall survival (OS). Detailed records of adverse events (AEs) will be maintained.To the best of our knowledge, this is the first study to investigate the use of Traditional Chinese Medicine as a monotherapy in patients with advanced colorectal cancer who have failed multiple lines of standard treatment.Trial registration: ClinicalTrials.gov NCT05897749. Registered on 09 May 2023.
Keywords: colorectal cancer, Chinese herbal medicine, randomized controlled trial, BJOEI, Progression-free survival
Received: 08 May 2025; Accepted: 11 Jul 2025.
Copyright: © 2025 Fang, Wang, Fang, Wang, Xie, Yang, Liu and Zhang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Ying Zhang, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.