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).
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.
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).
Parallel
Becotatug Vedotin
DrugThis 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.
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
overall survival
calculated from the date of randomisation to death
distant metastasis-free survival
calculated from the date of randomisation to the first distant metastasis
Locoregional failure-free survival
calculated from the date of randomisation to the first locoregional failure
Treatment-Related Adverse Events
graded according to NCI CTCAE v5.0
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Kai Hu
Lead sponsor
Guangxi Medical University
Sponsor institution
Wuzhou Red Cross Hospital
Collaborator
First People's Hospital of Yulin
Collaborator
Guigang People's Hospital
Collaborator
Hainan Cancer Hospital
Collaborator
Affiliated Hospital of North Sichuan Medical College
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
Hunan Cancer Hospital
Collaborator
Fujian Cancer Hospital
Collaborator
Guangxi Nanxishan Hospital
Collaborator
Liuzhou Workers' Hospital
Collaborator
Affiliated Hospital of Youjiang Medical University for Nationalitie
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
