Becotatug Vedotin Combined With Sintilimab and Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma：A Multicenter, Randomized, Controlled, Phase 3 Trial
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.
• Voluntarily participate in the study and sign the informed consent form in writing.
• Aged 18-70 years, male or non-pregnant female.
• Pathologically confirmed as nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or III).
• Staged as anyT N2-3 or T4N1 (9th AJCC/UICC staging) without distant metastasis.
• ECOG performance status score of 0-1.
• Hemoglobin (HGB) ≥ 90 g/L, neutrophil count ≥ 1.5×10⁹/L, and platelet (PLT) count ≥ 100×10⁹/L.
• Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN), and total bilirubin ≤ 1.5 times ULN.
• Normal renal function: Creatinine clearance rate ≥ 60 ml/min (calculated using the Cockcroft-Gault formula).
• Sexually active females of childbearing potential must agree to use effective contraceptive measures during treatment and for 1 year after the last administration of the study drug. Males who have sexual relations with females of childbearing potential must also agree to use effective contraceptive measures during treatment and for 1 year after the last administration of the study drug.