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NOT YET RECRUITING
NCT07238569
PHASE3

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

516

Start Date

2025-12-01

Completion Date

2031-05-23

Last Updated

2025-11-20

Healthy Volunteers

No

Interventions

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.