OncoMatch/Clinical Trials/NCT07459296
Becotatug Vedotin Plus Sintilimab in Locoregionally Advanced NPC
Is NCT07459296 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for nasopharyngeal carcinoma (npc).
Treatment: Becotatug Vedotin · Sintilimab · Cisplatin · Gemcitabine (GEM) · Cisplatin — This study is a multicenter, randomized, controlled phase III clinical trial aiming to investigate the efficacy and safety of Becotatug Vedotin induction therapy followed by concurrent chemoradiotherapy (CCRT) combined with neoadjuvant and adjuvant sintilimab, versus gemcitabine plus cisplatin (GP) induction chemotherapy followed by CCRT, in the treatment of high-risk locally advanced nasopharyngeal carcinoma (LANPC). The study plans to enroll 266 patients with high-risk NPC (AJCC 9th edition, anyT N2-3M0 or T4N1M0), who will be randomly assigned to the experimental group or the control group at a 1:1 ratio.The primary endpoint is 3-year event-free survival (EFS), and the secondary endpoints include overall survival (OS), local-regional failure-free survival (LRFFS), distant metastasis-free survival (DMFS), objective response rate (ORR), adverse events, and quality of life.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage ANYT N2-3, T4N1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radiotherapy
Cannot have received: systemic chemotherapy
Lab requirements
Blood counts
Hemoglobin ≥ 90 g/L, neutrophil count ≥ 1.5×10⁹/L, platelet count ≥ 100×10⁹/L
Kidney function
Creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula)
Liver function
ALT and AST ≤ 2.5 times ULN, total bilirubin ≤ 1.5 times ULN
Hemoglobin (HGB) ≥ 90 g/L, neutrophil count ≥ 1.5×10⁹/L, and platelet (PLT) count ≥ 100×10⁹/L. ALT and AST ≤ 2.5 times ULN, total bilirubin ≤ 1.5 times ULN. Creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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