[Translation] An evaluation of lymphatic tracer mitoxantrone hydrochloride injection for gastric cancer
Single-blind, single-center, safety, tolerability, pharmacokinetics, and dose-escalation and dose-expansion phase I/IIa clinical trial studies of lymphatic tracing in patients
本试验的目的是探索淋巴示踪用盐酸米托蒽醌注射液对胃癌患者淋巴示踪的有效性、安全性和耐受性并确定试验用药物最优使用剂量范围,同时探索淋巴示踪用盐酸米托蒽醌注射液对胃癌患者的药代动力学特征,为III 期临床试验的用
药剂量及评价指标提供合理依据。
[Translation] The purpose of this trial is to explore the efficacy, safety and tolerability of mitoxantrone hydrochloride injection for lymphatic tracing on lymphatic tracing in patients with gastric cancer, and to determine the optimal dose range of the experimental drug. Pharmacokinetic characteristics of mitoxantrone hydrochloride injection in patients with gastric cancer, which is used in phase III clinical trials.
Dosage and evaluation indicators provide a reasonable basis.