Becotatug Vedotin as Adjuvant Therapy For High-risk Nasopharyngeal Carcinoma

NCT07303283 | Not Yet Recruiting Phase 2

• 1 other identifier: GuangxiMUHK5
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Nasopharyngeal Carcinoma; Adjuvant therapy; Becotatug Vedotin

Outcome Measures

Primary Outcomes (1)

• event-free survival

  calculated from the date of randomisation to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first

  2 years

Secondary Outcomes (4)

• overall survival

  2 years

• distant metastasis-free survival

  2 years

• Locoregional failure-free survival

  2 years

• Treatment-Related Adverse Events

  2 years

Study Arms (2)

Adjuvant Becotatug Vedotin

EXPERIMENTAL

Adjuvant therapy with Becotatug Vedotin

Drug: Becotatug Vedotin

observation

NO INTERVENTION

Clinical follow-up and surveillance only

Interventions

Becotatug Vedotin DRUG

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.

Adjuvant Becotatug Vedotin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed non-keratinizing nasopharyngeal carcinoma(WHO II/III).
• Eligible patients with high-risk locoregionally advanced NPC, defined as AJCC (9th edition) stage T4N1M0 or Tany N2-3M0 disease, or persistent high-risk features after induction chemotherapy (SD, PD, or detectable plasma EBV DNA).
• ECOG performance status ≤1.
• Induction and concurrent chemoradiotherapy with the recommended regimen have been completed.
• No later than 6 weeks after the completion of the last radiotherapy treatment.
• Adequate hematologic (neutrophil count \> 1.5×10\^9/L, hemoglobin \> 90g/L and platelet count \> 100×10\^9/L), hepatic (alanine aminotransferase, aspartate aminotransferase ≤ 1.5×ULN, bilirubin ≤ 1.5×ULN, alkaline phosphatase \< 2.5×ULN) and renal function (creatinine clearance \> 50 ml/min)
• Patients must be informed of the investigational nature of this study and give written informed consent.
• Women of childbearing potential (WOCBP) who are sexually active must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of the study drug. Men who are sexually active with WOCBP must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of the study drug.

You may not qualify if:

• Patients who could not tolerate or were allergic to Becotatug Vedotin.
• Patients with severe chronic or active infection that must be treated with systemic antibacterial, antifungal, or antiviral therapy before randomization, including but not limited to tuberculosis infection.
• Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
• Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
• Interstitial lung disease or pneumonia requiring oral or intravenous steroid therapy within 1 year.
• Patients who are known to be intolerant or sensitive to any therapeutic agents.
• Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \> 1.5×ULN), and emotional disturbance.

Sponsors & Collaborators

• Hunan Cancer Hospital: collaborator
• Fujian Cancer Hospital: collaborator
• Kai Hu: lead
• Wuzhou Red Cross Hospital: collaborator
• Guigang People's Hospital: collaborator
• Hainan Cancer Hospital: collaborator
• Affiliated Hospital of North Sichuan Medical College: collaborator
• Affiliated Hospital of Youjiang Medical University for Nationalitie: collaborator
• Lingshan people's Hospital: collaborator
• LiuZhou People's Hospital: collaborator
• The Third people's hospital of Hechi: collaborator
• the second People's Hospital of qinzhou: collaborator
• First People's Hospital of Yulin: collaborator
• Guangxi Nanxishan Hospital: collaborator
• Liuzhou Workers' Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

kai hu

CONTACT

+867715359801; hukai@gxmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 24, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 31, 2030
• Study Completion (Estimated): August 31, 2033
• Last Updated: June 9, 2026

Record last verified: 2026-06

Locations

CN (1)