Fang Liyuan, Wang Yan, Fang Yuhang, Wang Runxi, Xie Yi, Yang Shuhan, Liu Suying, Zhang Ying
Department of Oncology, Guang'anmen Hospital of the Chinese Academy of Traditional Chinese Medicine, Beijing, China.
Graduate School, Beijing University of Chinese Medicine, Beijing, China.
Front Pharmacol. 2025 Jul 21;16:1610575. doi: 10.3389/fphar.2025.1610575. eCollection 2025.
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 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 2 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.
Clinicaltrials.gov, NCT05897749. Registered on 09 May 2023.
结直肠癌（CRC）是全球死亡率的重要促成因素。然而，现有的治疗方法往往难以取得理想的效果，尤其是在转移性结直肠癌中。鸦胆子油乳注射液（BJOEI）作为辅助治疗在临床实践中也显示出癌症治疗的优越性。本试验旨在收集初步数据，为一项III期临床试验提供信息，该试验将评估BJOEI联合最佳支持治疗（BSC）对所有现有治疗均难治的晚期结直肠癌患者的疗效和安全性。
本研究设计为一项多中心、随机对照临床试验。60名符合条件的参与者将按1:1的比例随机分配到试验组或对照组。试验组将接受BJOEI和BSC，而对照组将接受BSC。治疗将在疾病进展或毒性变得无法耐受时停止。随访评估将每2个月安排一次，持续到患者死亡、失访或随机分组后12个月。主要测量的结局将是无进展生存期（PFS）。待评估的其他结局包括临床症状、生活质量和总生存期（OS）。将详细记录不良事件（AE）。
据我们所知，这是第一项研究将中药作为单一疗法用于多线标准治疗失败的晚期结直肠癌患者的研究。
Clinicaltrials.gov，NCT05897749。于2023年5月9日注册。
