Becotatug Vedotin Plus Sintilimab in Locoregionally Advanced NPC

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorFirst Affiliated Hospital of Guangxi Medical University

About this trial

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 at a 1:1 ratio.The primary endpoint is 3-year event-free survival (EFS), and the secondary endpoints include overall survival (OS), local-regional failure-free survival (LRFFS), distant metastasis-free survival (DMFS), objective response rate (ORR), adverse events, and quality of life.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Aged > 70 years or < 18 years.

Patients with recurrent or distant metastatic nasopharyngeal carcinoma.

Pathologically confirmed as keratinizing squamous cell carcinoma (WHO type I).

Patients who have previously received radiotherapy or systemic chemotherapy.

Trial design

Treatments tested in this trial

  • Becotatug Vedotin
  • Sintilimab
  • Cisplatin
  • intensity-modulated radiotherapy
  • Gemcitabine (GEM)
  • Cisplatin

Treatment groups

266 Participants
are divided into 2 treatment groups

Sponsors and collaborators

First Affiliated Hospital of Guangxi Medical University

Lead sponsor

Xiangya Hospital of Central South University

Collaborator

First Affiliated Hospital of Fujian Medical University

Collaborator

Nanfang Hospital, Southern Medical University

Collaborator

Hunan Provincial Cancer Hospital

Collaborator

Affiliated Hospital of North Sichuan Medical College

Collaborator

First Hospital of China Medical University

Collaborator

Guangdong Provincial People's Hospital

Collaborator

First People's Hospital of Yulin

Collaborator

Wuzhou Red Cross Hospital

Collaborator

LiuZhou People's Hospital

Collaborator