Becotatug Vedotin as Adjuvant Therapy For High-risk Nasopharyngeal Carcinoma

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).

Conditions

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

Interventions

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.

Sponsors & Collaborators

• Wuzhou Red Cross Hospital

  collaborator OTHER

• First People's Hospital of Yulin

  collaborator OTHER

• Guigang People's Hospital

  collaborator OTHER

• Hainan Cancer Hospital

  collaborator OTHER

• Affiliated Hospital of North Sichuan Medical College

  collaborator OTHER

• Affiliated Hospital of Youjiang Medical University for Nationalitie

  collaborator UNKNOWN

• Lingshan people's Hospital

  collaborator UNKNOWN

• People's Hospital of Guangxi Zhuang Autonomous Region

  collaborator OTHER

• LiuZhou People's Hospital

  collaborator OTHER

• The Third people's hospital of Hechi

  collaborator UNKNOWN

• the second People's Hospital of qinzhou

  collaborator UNKNOWN

• Hunan Cancer Hospital

  collaborator OTHER

• Fujian Cancer Hospital

  collaborator OTHER_GOV

• Kai Hu

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-15

Primary Completion

2030-04-15

Completion

2033-04-15

Countries

• China

Study Locations