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Becotatug Vedotin Plus Sintilimab in Locoregionally Advanced NPC

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv2
  2. Study First Submitted
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.
Trial Details
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
(from sponsor)		 Nasopharyngeal Carcinoma (NPC)
Related terms Nasopharyngeal Carcinoma
Enrollment 266 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov