Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT07238569
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-20
First Post:
2025-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase III Trial of EBV-DNA-Guided Adaptive Immunotherapy for Advanced Nasopharyngeal Carcinoma
Sponsor:
Sun Yat-sen University
Organization:
Study Overview
Official Title:
Multicenter, Prospective Phase III Clinical Trial of EBV-DNA-Guided Adaptive Immunotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: