[Translation] A single-arm, single-multiple, 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 liver cancer
主要目的:评价三氧化二砷口服溶液用于晚期肝癌患者的安全性和耐受性,确定MTD。
次要目的:观察三氧化二砷口服溶液及其主要代谢产物的药代动力学特征。
探索性目的:探索三氧化二砷口服溶液治疗晚期肝癌患者的抗肿瘤疗效。
[Translation] Primary objective: To evaluate the safety and tolerability of arsenic trioxide oral solution in patients with advanced liver cancer and determine the MTD.
Secondary objective: To observe the pharmacokinetic characteristics of arsenic trioxide oral solution and its main metabolites.
Exploratory objective: To explore the anti-tumor efficacy of arsenic trioxide oral solution in the treatment of patients with advanced liver cancer.