Actively Recruiting
TN Induction and Adjuvant Therapy for Resectable Local Recurrent Nasopharyngeal Carcinoma
Led by Sun Yat-sen University · Updated on 2025-05-21
70
Participants Needed
1
Research Sites
205 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Investigators target recurrent nasopharyngeal carcinoma that can be resected surgically: rT1, rT2 (tumor confined to the surface of the parapharyngeal space, greater than 0.5cm from the internal carotid artery), rT3 (confined to the floor of the sphenoid sinus, greater than 0.5cm from the internal carotid artery/cavernous sinus) (AJCC 8th stage), A single-arm, phase II clinical trial was designed to investigate the efficacy and safety of triplizumab combined with nituzumab in induction and adjuvant treatment of operable local recurrent nasopharyngeal carcinoma.
CONDITIONS
Official Title
TN Induction and Adjuvant Therapy for Resectable Local Recurrent Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily participate and sign informed consent
- Aged 18 to 65 years, male or non-pregnant female
- Histologically or cytologically confirmed recurrent nasopharyngeal carcinoma
- Recurrence occurring more than 6 months after radiotherapy
- Recurrent nasopharyngeal carcinoma that is resectable (rT1, rT2 with tumor >0.5cm from internal carotid artery, rT3 confined to sphenoid sinus floor >0.5cm from critical arteries)
- If tumor invades or is close to internal carotid artery, preconditioning like embolization or stent implantation allowed
- ECOG performance status 0-1 with no serious dysfunction of vital organs
- Hemoglobin ≥90 g/L, white blood cells ≥4.0×10⁹/L, platelets ≥100×10⁹/L
- Liver function: ALT and AST less than 2.5 times upper limit normal, total bilirubin less than 2.0 times upper limit normal
- Renal function: serum creatinine less than 1.5 times upper limit normal
You will not qualify if you...
- Keratinized squamous cell carcinoma (WHO type I)
- Use of systemic or local glucocorticoid therapy within 4 weeks before enrollment
- Participation in other drug clinical trials within 3 months before treatment
- History of allogeneic organ or hematopoietic stem cell transplantation
- Idiopathic pulmonary fibrosis, drug-induced pneumonia, radiation pneumonia, active pneumonia, or moderate to severe lung disease requiring steroids
- Comorbidities requiring immunosuppressive drugs or corticosteroids
- Active or history of autoimmune diseases including interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, nephritis, thyroid disorders; vitiligo or resolved childhood asthma without intervention allowed
- Positive HBV DNA ≥1000 cps/ml or chronic hepatitis C with positive RNA
- Receipt of any anti-infection vaccine within 4 weeks before enrollment
- Positive pregnancy test or breastfeeding women
- Inability to comply with regular follow-up due to psychological, social, family, or geographic reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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