[Translation] An open-label, dose-escalation, multicenter phase I clinical study to evaluate the safety, tolerability, and pharmacokinetics of arsenic trioxide oral solution in patients with advanced hepatocellular carcinoma
第一阶段研究:
主要目的:
评价三氧化二砷口服溶液用于晚期肝细胞癌患者的安全性和耐受性,确定MTD和DLT。
次要目的: 1) 观察三氧化二砷口服溶液及其主要代谢物的药代动力学特征。
2) 以注射用三氧化二砷为参比制剂,以三氧化二砷口服溶液为受试制剂,对比其药代动力学参数。
第二阶段研究:
主要目的:
初步评价三氧化二砷口服溶液治疗晚期肝细胞癌患者的抗肿瘤疗效。
[Translation] Phase I study:
Main purpose:
To evaluate the safety and tolerability of arsenic trioxide oral solution in patients with advanced hepatocellular carcinoma and determine the MTD and DLT.
Secondary purpose: 1) To observe the pharmacokinetic characteristics of arsenic trioxide oral solution and its main metabolites.
2) To compare the pharmacokinetic parameters of arsenic trioxide for injection as the reference preparation and arsenic trioxide oral solution as the test preparation.
Phase II study:
Main purpose:
To preliminarily evaluate the anti-tumor efficacy of arsenic trioxide oral solution in the treatment of patients with advanced hepatocellular carcinoma.