drugset / Trial / NCT06554184

HR20013 for Nausea and Vomiting Associated With Moderate Emetic Risk Anticancer Agents

NCT06554184 ↗

Phase 3 Completed 706 enrolled Fujian Shengdi Pharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindPrevention

Summary

This study is aimed to evaluate the efficacy and safety of HR20013 versus palonosetron for nausea and vomiting associated with moderate emetic risk anticancer agents

Timeline

Start
2024-09-03
Primary completion
2025-07-28
Completion
2025-10-03

Outcome

Met primary endpoint

release “磷罗拉匹坦帕洛诺司琼(HR20013)联合地塞米松预防中致吐性化疗引起的恶心呕吐:一项随机、双盲Ⅲ期研究(PROTECT)结果正式亮相口头报告环节(摘要号:11006) [1] 。该研究由中山大学肿瘤防治中心 张力教授、李宇红教授 牵头,全国81家研究中心共同参与。研究结果显示 [1] ,磷罗拉匹坦帕洛诺司琼联合地塞米松组延迟期完全缓解(CR)率为79.0%,显著优于对照组(P<0.001)” hengrui.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject HR20013 Other / unclassified — —
Comparator Palonosetron Other / unclassified — —
Comparator Dexamethasone Small molecule — —