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
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