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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).

Phase 3RecruitingFirst Affiliated Hospital of Guangxi Medical UniversityNCT07459296Data as of May 2026

Treatment: Becotatug Vedotin · Sintilimab · Cisplatin · Gemcitabine (GEM) · CisplatinThis 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.

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Extracted 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

No prior treatment (treatment-naive required)
Max 0 prior lines

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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