drugset / Trial / NCT05772208

Intensified Treatments for Patients With Locally Advanced Nasopharyngeal Carcinoma With Detectable EBV DNA After One Cycle GP Regime Neoadjuvant Chemotherapy

NCT05772208

Phase 3 Recruiting 459 enrolled Fudan University
RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this multicenter randomized non-inferior study is to compare the additon of camrelizumab or nimotuzumab to neoadjuvant chemotherapy followed by concurrent chemoradiotherapy in locally advanced nasopharyngeal carcinoma patients whose EBV DNA remained detectable after one cycle neoadjuvant chemotherapy using GP regimen. The main question it aims to answer is: whether the addition of carrilizumab or nituzumab improve the treatment outcomes in the relatively poor prognostic patients identified by the response of EBV DNA. Participants will be randomized to the combination of carrilizumab and standard treatment , the combination of nituzumab and standard treatment or the standard treatment alone if their EBV DNA didn't decrease to undetectable level post first cycle of neoadjuvant chemotherapy.

Timeline

Start
2022-01-01
Primary completion
2025-01-01
Completion
2028-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Camrelizumab Monoclonal antibody 200 mg
Subject Nimotuzumab Monoclonal antibody 200 mg
Background Cisplatin Other / unclassified 75 mg/m2
Background Cisplatin Other / unclassified 80 mg/m2
Background Gemcitabine Small molecule 1 g