Becotatug Vedotin Plus Sintilimab in Locoregionally Advanced NPC

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.

NCT Number	NCT07459296
Lead Sponsor	First Affiliated Hospital of Guangxi Medical University Collaborators: Xiangya Hospital of Central South University, First Affiliated Hospital of Fujian Medical University, Nanfang Hospital, Southern Medical University, Hunan Provincial Cancer Hospital, Affiliated Hospital of North Sichuan Medical College, First Hospital of China Medical University, Guangdong Provincial People's Hospital, First People's Hospital of Yulin, Wuzhou Red Cross Hospital, LiuZhou People's Hospital
Conditions	Nasopharyngeal Carcinoma (NPC)
Enrollment	266 participants
Start Date	2026-03-05
Primary Completion	2030-04-01 (estimated)
Study Completion	2032-04-01 (estimated)
Updated on ClinicalTrials.gov	2026-03-16