NCT07303283

Becotatug Vedotin as Adjuvant Therapy For High-risk Nasopharyngeal Carcinoma

Becotatug Vedotin Versus Capecitabine as Adjuvant Therapy for Locoregional Advanced Nasopharyngeal Carcinoma: a Multicentre, Open-label, Parallel-group, Randomised, Controlled, Phase 2 Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 218 (estimated)
• Sponsor: Kai Hu · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2, multicentre, open-label, randomised, controlled trial with a parallel-group design. The study aims to compare the efficacy and safety of Becotatug Vedotin and capecitabine as an adjuvant therapy in patients with high-risk locoregionally advanced nasopharyngeal carcinoma (NPC).

Detailed description

Eligible patients with high-risk locoregionally advanced nasopharyngeal carcinoma (NPC), staged as T4 N1 M0 or T any N2-3 M0, who have completed curative chemoradiotherapy, will be randomized to either an metronomic capecitabine group or an adjuvant Becotatug Vedotin group. Participants in the experimental group will receive Becotatug Vedotin at a dose of 2.3 mg/kg administered intravenously on Day 1 of each 21-day cycle for a total of three cycles. Participants in the control group will receive metronomic capecitabine at a dose of 650 mg/m² orally twice daily for one year. The primary endpoint is failure-free survival (FFS). Secondary endpoints include overall survival (OS), distant metastasis-free survival (D-MFS), locoregional failure-free survival (LR-FFS), and treatment-emergent adverse events. All efficacy analyses will be performed on an intention-to-treat (ITT) basis. Safety analyses will be conducted in the safety population, defined as all patients who received at least one dose of the assigned study treatment.

Conditions

• Nasopharyngeal Carcinoma (NPC)
• Locoregionally Advanced Nasopharyngeal Carcinoma
• Adjuvant Therapy

Interventions

Type	Name	Description
DRUG	Becotatug Vedotin	This group will receive Becotatug Vedotin at a dose of 2.3 mg/kg on day 1 of each 3-week cycle for a total of 3 cycles.
DRUG	capecitabine	This group will receive metronomic capecitabine at a dose of 650 mg/m² orally twice daily for one year.

Timeline

• Start date: 2026-04-15
• Primary completion: 2030-04-15
• Completion: 2033-04-15
• First posted: 2025-12-24
• Last updated: 2026-03-05

Locations

1 site across 1 country: China