drugset / Trial / NCT07392320

A Phase II Trial Comparing Immunotherapy Versus Capecitabine Maintenance After Chemo-chemoradiotherapy for High-risk Nasopharyngeal Carcinoma

NCT07392320

Phase 2 Recruiting 142 enrolled Sun Yat-sen University
RandomizedParallel-groupOpen-labelTreatment

Summary

In this study, the investigators designed a randomized, open-label, phase II clinical trial for high-risk locally advanced nasopharyngeal carcinoma (T4 or N3 or EBV DNA ≥1500 copies/ml, AJCC 9th edition) that is sensitive to chemotherapy and PD-1 monoclonal antibody therapy. The trial compares sequential treatment with the TP regimen combined with PD-1 monoclonal antibody followed by concurrent chemoradiotherapy and PD-1 maintenance therapy versus capecitabine maintenance therapy. The aim is to provide high-quality clinical evidence for optimizing the treatment strategy for high-risk locally advanced nasopharyngeal carcinoma.

Timeline

Start
2026-02-10
Primary completion
2031-02-10
Completion
2033-02-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1000 mg/m2
Subject Penpulimab Monoclonal antibody 200 mg
Background Cisplatin Other / unclassified 75 mg/m2
Background Cisplatin Other / unclassified 100 mg/m2
Background Docetaxel Small molecule 75 mg/m2