NCT07238569

Phase III Trial of EBV-DNA-Guided Adaptive Immunotherapy for Advanced Nasopharyngeal Carcinoma

Multicenter, Prospective Phase III Clinical Trial of EBV-DNA-Guided Adaptive Immunotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 516 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This trial evaluated the efficacy of two adjuvant regimens following identical induction and concurrent chemoradiotherapy (IC+CCRT) in locoregionally advanced nasopharyngeal carcinoma (LANPC) patients with persistent EBV DNA positivity or stable disease after three IC cycles. The control arm received adjuvant adebrelimab, while the experimental arm received adebrelimab plus capecitabine.

Detailed description

This study will enroll patients with stage II-III LANPC (AJCC 9th edition, excluding T3N0-1). After three cycles of induction chemotherapy (gemcitabine, cisplatin, and adebrelimab), eligible patients with persistent EBV DNA or stable disease will be randomized 1:1. All patients will undergo CCRT followed by adjuvant therapy. The control arm will receive five cycles of adebrelimab. The experimental arm will receive five cycles of adebrelimab in combination with capecitabine, which will be administered for one year.

Conditions

• Nasopharyngeal Cancinoma (NPC)
• Nasopharangeal Cancer

Interventions

Type	Name	Description
DRUG	Adebrelimab (PD-L1 inhibitor)	Adebrelimab 1200mg will be given every 3 weeks for 5 cycles in adjuvant chemotherapy
DRUG	Cisplatin (100mg/m2)	Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation; Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation
RADIATION	Intensity-modulated radiotherapy	Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions.
DRUG	Capecitabine	Capecitabine was administered at 650 mg/m² orally twice daily for one year.

Timeline

• Start date: 2025-12-01
• Primary completion: 2029-12-01
• Completion: 2031-05-23
• First posted: 2025-11-20
• Last updated: 2025-11-20