Wu Jingyuan, Ge Yuansha, Zhu Guanghui, Gao Ruike, Zhu Xiaoyu, Zhang Ying, Li Jie
Oncology Department, Guang'anmen Hospital, China, Academy of Chinese Medical Sciences, Beixian Pavilion, No.5, Xicheng District, Beijing, China.
Graduate School, Beijing University of Chinese Medicine, Beijing, China.
BMC Complement Med Ther. 2024 Dec 31;24(1):429. doi: 10.1186/s12906-024-04725-6.
The treatment of advanced colorectal cancer (CRC) has progressed slowly, with chemotherapy combined with targeted therapy being the first-line treatment for the disease, but the improvement in efficacy is not satisfactory. Compound Kushen injection (CKI) is one of the representative drugs of anti-cancer Chinese herbal injection drugs, which has been widely used in the adjunct treatment of cancer in China. The aim of this trial is to evaluate the efficacy and safety of CKI combined with first-line treatment of advanced CRC.
This is a multicenter, randomized, open-label controlled clinical trial in which 320 patients with advanced CRC will be randomly assigned to the treatment group or the control group in a 1:1 ratio. Both groups will receive at least 4 cycles of first-line therapy (FOLFOX/FOLFIRI/CAPEOX ± cetuximab/bevacizumab) in 14-21 day cycles, and the experimental group will receive additional CKI with a cumulative dose of 200 ml per cycle. Patients who achieve a complete response, partial response, or stable disease after 4-6 months will receive maintenance therapy until disease progression or another endpoint event, such as toxicity or death, occurs.. Follow-up will occur every 3 months until death or loss to follow-up. The primary outcome of this study will be progression-free survival (PFS). Secondary outcomes will be overall survival (OS), 1-year OS rate, 1-year PFS rate, objective response rate,disease control rate, symptoms and quality of life evaluation. Safety outcomes will be incidence of adverse events.
This study will be the first randomized controlled trial to investigate the efficacy and safety of CKI when combined with first-line treatment in the treatment of advanced CRC, with PFS as the primary outcome. It aims to clarify the clinical advantages and therapeutic effect of CKI in the treatment of advanced CRC. To identify the benefit population of CKI in the treatment of patients with advanced CRC, an enrichment design based on biomarkers will be utilized. Metabolomics and gut microbiota analysis will be conducted on biological samples to explore the metabolic and gut microbiota differences associated with the efficacy of CKI, guiding further research into its mechanism of action.
ClinicalTrials.govNCT05894694. Registered on 4 August 2023.
晚期结直肠癌（CRC）的治疗进展缓慢，化疗联合靶向治疗是该病的一线治疗方法，但疗效改善并不令人满意。复方苦参注射液（CKI）是抗癌中药注射剂的代表性药物之一，在中国已广泛用于癌症的辅助治疗。本试验的目的是评估CKI联合一线治疗晚期CRC的疗效和安全性。
这是一项多中心、随机、开放标签的对照临床试验，320例晚期CRC患者将按1:1的比例随机分配至治疗组或对照组。两组均接受至少4个周期的一线治疗（FOLFOX/FOLFIRI/CAPEOX±西妥昔单抗/贝伐单抗），周期为14 - 21天，试验组每周期额外接受累积剂量为200 ml的CKI。在4 - 6个月后达到完全缓解、部分缓解或疾病稳定的患者将接受维持治疗，直至疾病进展或出现其他终点事件，如毒性反应或死亡。每3个月进行一次随访，直至死亡或失访。本研究的主要结局将是无进展生存期（PFS）。次要结局将是总生存期（OS）、1年OS率、1年PFS率、客观缓解率、疾病控制率、症状及生活质量评估。安全性结局将是不良事件的发生率。
本研究将是首个以PFS为主要结局，探究CKI联合一线治疗晚期CRC疗效和安全性的随机对照试验。旨在阐明CKI在治疗晚期CRC中的临床优势和治疗效果。为确定CKI在治疗晚期CRC患者中的受益人群，将采用基于生物标志物的富集设计。将对生物样本进行代谢组学和肠道微生物群分析，以探索与CKI疗效相关的代谢和肠道微生物群差异，指导对其作用机制的进一步研究。
ClinicalTrials.govNCT05894694。于2023年8月4日注册。
