Actively Recruiting
Becotatug Vedotin Combined With Sintilimab and Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: A Multicenter, Randomized, Controlled, Phase 3 Trial
Led by First Affiliated Hospital of Guangxi Medical University · Updated on 2026-03-16
266
Participants Needed
1
Research Sites
104 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
Researchers are evaluating the effectiveness and safety of a new treatment approach for patients with high-risk locally advanced nasopharyngeal carcinoma (LANPC). This phase III clinical trial compares an experimental regimen including Becotatug Vedotin induction therapy followed by concurrent chemoradiotherapy (CCRT) combined with neoadjuvant and adjuvant sintilimab, against the standard treatment of gemcitabine plus cisplatin (GP) induction chemotherapy followed by CCRT. The study aims to provide evidence on improving 3-year event-free survival and other important outcomes like overall survival and quality of life in this patient group. Participants are randomly assigned to one of two groups. The experimental group receives three cycles of Becotatug Vedotin and sintilimab every three weeks, followed by CCRT with cisplatin and nine cycles of adjuvant sintilimab. The control group receives three cycles of gemcitabine plus cisplatin chemotherapy every three weeks before CCRT. All patients undergo intensity-modulated radiotherapy (IMRT) with a precise radiation dose over 33 fractions. The study includes detailed protocols for adjusting drug doses and monitoring side effects according to standard criteria. Throughout the study, participants will be closely monitored for treatment response, adverse events, and quality of life using validated scales and laboratory tests. Researchers will assess survival outcomes and track safety for up to three years. Biomarker analysis will also be performed to explore personalized treatment options. Patients' health status, blood counts, organ function, and potential side effects will be regularly evaluated to manage treatment safely during the trial period.
CONDITIONS
Brief 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 between 18 and 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 at least 90 g/L, neutrophil count at least 1.5×10⁹/L, and platelet count at least 100×10⁹/L
- Liver function with ALT and AST no more than 2.5 times the upper normal limit, and total bilirubin no more than 1.5 times the upper normal limit
- Normal kidney function with creatinine clearance rate at least 60 ml/min
- Sexually active females of childbearing potential and males with partners of childbearing potential must agree to use effective contraception during treatment and for one year after last study drug administration
You will not qualify if you...
- Age below 18 or above 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 viral DNA levels
- Positive for hepatitis C virus antibody
- Active autoimmune diseases requiring systemic treatment, except certain controlled conditions
- Use of systemic glucocorticoids or immunosuppressive therapy within 28 days before consent
- History of active tuberculosis within past year
- History of other malignant tumors within past 5 years, except some cured skin or thyroid cancers
- History of interstitial lung disease
- Recent or planned live vaccine administration
- Pregnant or breastfeeding females
- Known hypersensitivity to study drugs
- Known HIV infection
- Any condition that may affect ability to consent or participate, including serious heart conditions, active infections, mental illness, or social issues
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 to 7 months depending on treatment phase
Participants receive induction therapy followed by concurrent chemoradiotherapy. The experimental group receives becotatug vedotin plus sintilimab for 3 cycles, then cisplatin with radiation and adjuvant sintilimab for 9 cycles. The control group receives gemcitabine plus cisplatin induction chemotherapy for 3 cycles followed by cisplatin concurrent with radiation.
Multiple visits every 3 weeks during induction, chemoradiotherapy, and adjuvant phases
Duration - Up to 3 years
Participants are monitored for event-free survival, overall survival, recurrence, adverse events, and quality of life for up to 3 years after treatment.
Regular visits over 3 years for assessments
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
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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