Zhang Zhidong, Zhao Qun, Fan Liqiao, Wang Dong, Zhao Xuefeng, Tan Bibo, Liu Yu, Liu Qingwei, Li Zhaoxing, Yang Peigang, Ding Ping'an, Wang Zhixin, Yang Li, Wang Shujun, Li Yong
The Third Department of Surgery, The Fourth Hospital of Hebei Medical University Shijiazhuang 050011, Hebei, China.
Department of CT/MRI, The Fourth Hospital of Hebei Medical University Shijiazhuang 050011, Hebei, China.
Am J Cancer Res. 2024 Apr 15;14(4):1675-1684. doi: 10.62347/LSDV5580. eCollection 2024.
Mitoxantrone Hydrochloride Injection for Tracing (MHI), a modified new drug marketed in China, has been approved by the National Medical Products Administration for lymph node tracing in thyroid cancer and sentinel lymph node biopsy in breast cancer. This single-center, single-blind, dose-escalation phase I clinical trial aimed to investigate the safety of MHI on lymph node tracing in gastric cancer. In this study, four dose groups (1.0 mL, 1.5 mL, 2.0 mL, and 3.0 mL) with 3 gastric cancer patients in each group were set. The safety, tolerability, pharmacokinetics and preliminary efficacy of different doses were investigated. Results showed that none of the patients experienced dose-limiting toxicity or developed serious adverse events or adverse drug reactions. Pharmacokinetic analyses revealed minimal absorption of the tracer, resulting in low and transient blood drug concentrations across all participants. The mean time to peak concentration was (0.561 ± 0.3728) h (with mean peak concentration (C) of 10.300 ng/mL), (0.500 ± 0.0167) h (mean C of 13.687 ng/mL), (0.494 ± 0.0096) h (mean C of 30.933 ng/mL), and (0.661 ± 0.2791) h (mean C of 21.067 ng/mL) in the 1.0 mL, 1.5 mL, 2.0 mL, and 3.0 mL dose groups, respectively. The mean lymph node staining rates were 21.0%, 24.7%, 32.5%, and 44.5%, and the mean metastatic lymph node staining rates were 20.6%, 36.1%, 42.4%, and 21.0% in each group. This study confirmed that MHI was safe, well-tolerated, and had low systemic effects when used for lymphatic tracing of gastric cancer, and the tracing effect was better in the 3 mL dose group. This trail was registered on the website of Centre for Drug Evaluation State Drug and Food Administration (http://www.chinadrugtrials.org.cn/index.html) with the name of clinical study of lymphatic tracer in lymph node tracing of gastric cancer, the code was CTR20201906.
注射用盐酸米托蒽醌示踪剂（MHI）是一种在中国上市的改良型新药，已获国家药品监督管理局批准用于甲状腺癌淋巴结示踪及乳腺癌前哨淋巴结活检。这项单中心、单盲、剂量递增的I期临床试验旨在研究MHI用于胃癌淋巴结示踪的安全性。本研究设置了四个剂量组（1.0 mL、1.5 mL、2.0 mL和3.0 mL），每组3例胃癌患者。研究了不同剂量的安全性、耐受性、药代动力学及初步疗效。结果显示，所有患者均未出现剂量限制性毒性，也未发生严重不良事件或药物不良反应。药代动力学分析显示，示踪剂吸收极少，所有受试者的血药浓度均较低且呈一过性。1.0 mL、1.5 mL、2.0 mL和3.0 mL剂量组的平均达峰时间分别为（0.561±0.3728）h（平均峰浓度（C）为10.300 ng/mL）、（0.500±0.0167）h（平均C为13.687 ng/mL）、（0.494±0.0096）h（平均C为30.933 ng/mL）和（0.661±0.2791）h（平均C为21.067 ng/mL）。各组的平均淋巴结染色率分别为21.0%、24.7%、32.5%和44.
