drugset / Trial / NCT03387774

Efficacy of Ulinastatin for Reducing Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma Patients

NCT03387774

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a phase 3, open-label, multicenter, randomized controlled phase III clinical trial. The purpose of this study is to evaluate the efficacy of ulinastatin, a kind of protease inhibitor, in the treatment of radiation-induced acute oral mucositis in localregionally advanced nasopharyngeal carcinoma(NPC) patients treated with concurrent chemoradiotherapy(CCRT). To Explore a new and efficient way to reduce the incidence and severity of radiation-induced acute oral mucositis.

Timeline

Start
2018-01-30
Primary completion
2021-12-28
Completion
2024-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Ulinastatin Protein / enzyme biologic Intravenous
Background Cisplatin Other / unclassified 100 mg/m2 Intravenous

Indications