NCT07392320

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

A Randomized, Open-Label, Phase II Clinical Study Comparing Immunotherapy Combined With Induction Chemotherapy Followed by Concurrent Chemoradiotherapy and Immunotherapy Maintenance Versus Capecitabine Maintenance in Locally Advanced High-Risk Nasopharyngeal Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

For high-risk locally advanced nasopharyngeal carcinoma, it remains essential to explore more effective treatment strategies and regimens. In the era of immunotherapy, the introduction of PD-1 monoclonal antibodies has provided significant survival benefits to patients with locally advanced nasopharyngeal carcinoma. However, different modes of intervention still warrant further exploration, and additional clinical evidence is needed for validation. In this study, the investigators designed a randomized, open-label, phase II clinical trial focusing on high-risk locally advanced nasopharyngeal carcinoma (defined as T4 or N3 or EBV DNA ≥1500 copies/ml according to AJCC 9th edition) that is sensitive to chemotherapy and PD-1 monoclonal antibody therapy. The trial compares the sequential approach of TP regimen combined with PD-1 monoclonal antibody followed by concurrent chemoradiotherapy and PD-1 maintenance therapy versus maintenance therapy with capecitabine. The study aims to provide high-quality clinical evidence to optimize treatment strategies for high-risk locally advanced nasopharyngeal carcinoma.

Conditions

• Nasopharangeal Cancer

Interventions

Type	Name	Description
DRUG	TP+PD1+CCRT	Induction Chemoimmunotherapy (3 cycles, Q3W): Induction chemotherapy consisted of three cycles of docetaxel (75 mg/m², day 1), cisplatin (75 mg/m², day 1), and penpulimab (200 mg, day 1), administered every 3 weeks. Concurrent Chemotherapy (3 weeks post-induction, 2 cycles, Q3W): concurrent cisplatin 100mg/m2 every 21days for two cycles during Intensity modulated-radiotherapy (IMRT)
DRUG	PD-1 Monoclonal Antibody	Penpulimab 200 mg every 3 weeks for 8 cycles
DRUG	Capecitabine	Capecitabine 1000 mg/m² BID, days 1-14, for 8 cycles.

Timeline

• Start date: 2026-02-04
• Primary completion: 2031-02-04
• Completion: 2033-02-04
• First posted: 2026-02-06
• Last updated: 2026-02-06

Locations

1 site across 1 country: China