drugset / Trial / NCT07392320
A Phase II Trial Comparing Immunotherapy Versus Capecitabine Maintenance After Chemo-chemoradiotherapy for High-risk Nasopharyngeal Carcinoma
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |