Becotatug Vedotin Plus Sintilimab in Locoregionally Advanced NPC

This study is a multicenter, randomized, controlled phase III clinical trial aiming to investigate the efficacy and safety of Becotatug Vedotin induction therapy followed by concurrent chemoradiotherapy (CCRT) combined with neoadjuvant and adjuvant sintilimab, versus gemcitabine plus cisplatin (GP) induction chemotherapy followed by CCRT, in the treatment of high-risk locally advanced nasopharyngeal carcinoma (LANPC). The study plans to enroll 266 patients with high-risk NPC (AJCC 9th edition, anyT N2-3M0 or T4N1M0), who will be randomly assigned to the experimental group or the control group

Trial Details

NCT ID
NCT07459296
Phase
PHASE3
Sponsor
First Affiliated Hospital of Guangxi Medical University
Status
RECRUITING
Cancer Type
Nasopharyngeal Head and Neck Cancer
Interventions
  • Becotatug Vedotin
  • Sintilimab
  • Cisplatin
  • intensity-modulated radiotherapy
  • Gemcitabine (GEM)
Locations (sample)
  • Nanning, Guangxi, China|22.81667,108.31667

Key Eligibility Criteria

  • Voluntarily participate in the study and sign the informed consent form in writing.
  • Aged 18-70 years, male or non-pregnant female.
  • Pathologically confirmed as nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or III).
  • Staged as anyT N2-3 or T4N1 (9th AJCC/UICC staging) without distant metastasis.

For full eligibility, visit ClinicalTrials.gov.

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