Becotatug Vedotin Plus Sintilimab in Locoregionally Advanced NPC
Summary
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.
Timeline
- Start
- 2026-03-05
- Primary completion
- 2030-04-01
- Completion
- 2032-04-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Becotatug Vedotin | Monoclonal antibody | 2.3 mg/kg | — |
| Comparator | Cisplatin | Other / unclassified | 100 mg/m2 | — |
| Comparator | Gemcitabine | Small molecule | 1 g | — |
| Subject | Sintilimab | Monoclonal antibody | 200 mg | — |