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
1 other identifier
interventional
218
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2026
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2025
CompletedFirst Posted
Study publicly available on registry
December 24, 2025
CompletedStudy Start
First participant enrolled
April 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 15, 2033
March 5, 2026
March 1, 2026
4 years
December 11, 2025
March 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
failure-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 (AEs)
5 years
Study Arms (2)
Adjuvant Becotatug Vedotin
EXPERIMENTALAdjuvant therapy with Becotatug Vedotin
control
OTHERmetronomic capecitabine
Interventions
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.
This group will receive metronomic capecitabine at a dose of 650 mg/m² orally twice daily for one year.
Eligibility Criteria
You may qualify if:
- Histologically confirmed non-keratinizing nasopharyngeal carcinoma(WHO II/III).
- Original clinical staged as TanyN2-3M0 or T4N1M0 (according to AJCC 9th edition), with no evidence of distant metastasis.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hunan Cancer Hospitalcollaborator
- Fujian Cancer Hospitalcollaborator
- Kai Hulead
- Wuzhou Red Cross Hospitalcollaborator
- First People's Hospital of Yulincollaborator
- Guigang People's Hospitalcollaborator
- Hainan Cancer Hospitalcollaborator
- Affiliated Hospital of North Sichuan Medical Collegecollaborator
- Affiliated Hospital of Youjiang Medical University for Nationalitiecollaborator
- Lingshan people's Hospitalcollaborator
- People's Hospital of Guangxi Zhuang Autonomous Regioncollaborator
- LiuZhou People's Hospitalcollaborator
- The Third people's hospital of Hechicollaborator
- the second People's Hospital of qinzhoucollaborator
Study Sites (1)
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
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
April 15, 2026
Primary Completion (Estimated)
April 15, 2030
Study Completion (Estimated)
April 15, 2033
Last Updated
March 5, 2026
Record last verified: 2026-03