评估示踪用盐酸米托蒽醌注射液用于胃癌根治术患者淋巴示踪的有效性和安全性多中心、随机、单盲、阳性平行对照优效临床研究
[Translation] A multicenter, randomized, single-blind, positive parallel controlled clinical study to evaluate the efficacy and safety of mitoxantrone hydrochloride injection for lymph node tracing in patients undergoing radical gastrectomy for gastric cancer
评估示踪用盐酸米托蒽醌注射液对比纳米炭混悬注射液对胃癌手术患者淋巴示踪的有效性和安全性。
[Translation] To evaluate the effectiveness and safety of mitoxantrone hydrochloride injection versus carbon nanoparticle suspension injection in lymph node tracing in patients undergoing gastric cancer surgery.
一项评价淋巴示踪用盐酸米托蒽醌注射液用于胃癌
患者淋巴示踪的单盲、单中心、安全性、耐受性、药代动力学特征及初步疗效的剂量递增和剂量扩展的I期/IIa 期临床试验研究
[Translation] A single-blind, single-center, dose-escalation and dose-expansion clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of mitoxantrone hydrochloride injection for lymphatic tracing in patients with gastric cancer.
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 effectiveness, safety and tolerability of mitoxantrone hydrochloride injection for lymphatic tracing in patients with gastric cancer and determine the optimal dosage range of the trial drug. At the same time, it is to explore the pharmacokinetic characteristics of mitoxantrone hydrochloride injection for lymphatic tracing in patients with gastric cancer, and to provide a reasonable basis for the dosage and evaluation indicators of the Phase III clinical trial.
淋巴示踪用盐酸米托蒽醌注射液用于乳腺癌手术前哨淋巴结示踪的有效性和安全性的多中心、阳性、自身对照临床
[Translation] A multicenter, positive, self-controlled clinical trial of the efficacy and safety of mitoxantrone hydrochloride injection for sentinel lymph node tracing before breast cancer surgery
评价试验药物对乳腺癌受试者前哨淋巴结示踪的有效性与安全性。
[Translation] To evaluate the effectiveness and safety of investigational drugs in sentinel lymph node tracing in subjects with breast cancer.
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