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

NCT07238569 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 516

Last updated 2025-11-20

No results posted yet for this study

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.

Conditions

  • Nasopharyngeal Cancinoma (NPC)
  • Nasopharangeal Cancer

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.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2029-12-01
Completion
2031-05-23

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07238569 on ClinicalTrials.gov