[Translation] A single-center, randomized, single-blind, dose-finding phase IIa and human pharmacokinetic clinical trial of doxifluridine injection in the treatment of advanced gastric cancer and breast cancer
(1)初步探索注射用去氧氟尿苷高、中、低不同剂量治疗晚期乳腺癌、胃癌的有效性和安全性; (2)观察乳腺癌、胃癌等患者单剂量和多剂量静脉滴注注射用去氧氟尿苷后药物的体内经时过程,估计其药代动力学参数,并与患者静脉滴注5-FU后的药代动力学参数比较,为临床用药提出指导。
[Translation] (1) To preliminarily explore the efficacy and safety of high, medium and low doses of doxifluridine for injection in the treatment of advanced breast cancer and gastric cancer; (2) To observe the in vivo time course of the drug after single and multiple doses of intravenous infusion of doxifluridine for injection in patients with breast cancer, gastric cancer, etc., estimate its pharmacokinetic parameters, and compare them with the pharmacokinetic parameters of patients after intravenous infusion of 5-FU, so as to provide guidance for clinical drug use.