Actively Recruiting
Becotatug Vedotin Plus Sintilimab in Locoregionally Advanced NPC
Led by First Affiliated Hospital of Guangxi Medical University · Updated on 2026-03-16
266
Participants Needed
1
Research Sites
317 weeks
Total Duration
On this page
Sponsors
F
First Affiliated Hospital of Guangxi Medical University
Lead Sponsor
X
Xiangya Hospital of Central South University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Becotatug Vedotin Plus Sintilimab in Locoregionally Advanced NPC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Aged 18 to 70 years, male or non-pregnant female
- Diagnosed with nasopharyngeal non-keratinizing carcinoma (WHO type II or III)
- Staged as anyT N2-3 or T4N1 without distant metastasis (9th AJCC/UICC staging)
- ECOG performance status score of 0 or 1
- Hemoglobin level at least 90 g/L, neutrophil count at least 1.5x10^9/L, and platelet count at least 100x10^9/L
- Liver function with ALT and AST no more than 2.5 times upper limit of normal and total bilirubin no more than 1.5 times upper limit
- Normal kidney function with creatinine clearance rate at least 60 ml/min
- Females of childbearing potential and males with partners agree to use effective contraception during treatment and for 1 year after last study drug administration
You will not qualify if you...
- Younger than 18 or older than 70 years
- Recurrent or distant metastatic nasopharyngeal carcinoma
- Diagnosed with keratinizing squamous cell carcinoma (WHO type I)
- Previous radiotherapy or systemic chemotherapy
- Positive for hepatitis B surface antigen with high HBV DNA levels
- Positive for hepatitis C virus antibody
- Active autoimmune diseases except controlled type 1 diabetes, hypothyroidism, or mild skin conditions
- Recent use of systemic glucocorticoids (above 10 mg/day prednisone equivalent) or immunosuppressive therapy within 28 days
- Active tuberculosis within past year
- History of other cancers except cured basal cell carcinoma or carcinoma in situ of cervix
- History of interstitial lung disease
- Receipt or planned receipt of live vaccines within 30 days
- Pregnant or breastfeeding females
- History of other cancers within past 5 years except certain treated skin or thyroid cancers
- Known allergy to study drugs (gemcitabine, cisplatin, becotatug vedotin, or sintilimab)
- Known HIV infection
- Conditions that impair ability to consent or participate such as serious heart disease, infections, mental illness, or social issues
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
Actively Recruiting
Research Team
M
Min Kang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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