TN Induction and Adjuvant Therapy for Resectable Local Recurrent Nasopharyngeal Carcinoma

Launched by SUN YAT-SEN UNIVERSITY · Apr 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with a specific type of nasopharyngeal carcinoma, which is a type of cancer located in the area behind the nose and above the back of the throat. The trial aims to see how effective and safe a combination of two drugs, triplizumab and nituzumab, is when given before and after surgery for patients whose cancer can be surgically removed. It is designed for adults aged 18 to 65 who have a confirmed diagnosis of recurrent nasopharyngeal carcinoma and have not received treatment for at least six months after their last radiation therapy.

To participate in this trial, patients must meet certain criteria, including having a specific type of cancer that hasn’t invaded nearby important structures, and they must be in good overall health without serious heart, lung, or liver problems. Participants will be monitored closely throughout the trial to assess how well the treatment works and to check for any side effects. It's important to note that this trial is not yet recruiting patients, so those interested will need to wait until it begins.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Voluntarily participate in and sign the informed consent in person. 2. Aged 18-65 years, male or non-pregnant female. 3. Histologically and/or cytologically confirmed recurrent nasopharyngeal carcinoma (keratinized or non-keratinized carcinoma; Differentiated or undifferentiated) 4. Patients with recurrence time more than 6 months from the end of radiotherapy; 5. Recurrent nasopharyngeal carcinoma that can be resectable: rT1, rT2 (the tumor is confined to the surface of the parapharyngeal space, and the distance from the internal carotid artery is greater than that from the internal carotid artery 0.5cm), rT3 (confined to the floor wall of the sphenoid sinus, greater than 0.5cm from the internal carotid artery/cavernous sinus) (AJCC 8th stage).
• • If the tumor invades the internal carotid artery, or is less than 0.5cm away from the internal carotid artery, but the invasion scope does not exceed the external edge of the internal carotid artery, it can be advanced Internal carotid artery preconditioning (including internal carotid artery embolization or stent implantation) was followed.
• • 6. ECOG score 0-1, no serious dysfunction of heart, lung, liver, kidney and other vital organs.
• • 7. Hemoglobin (HGB) ≥90 g/L, white blood cells (WBC) ≥4.0×109 /L, platelets (PLT) ≥100×109 /L.
• • 8. Liver function: ALT and AST\< 2.5 times the upper limit of normal (ULN), total bilirubin \<2.0×ULN.
• • 9. Renal function: serum creatinine \<1.5×ULN.
• Exclusion Criteria:
• • 1. The pathological findings were keratinized squamous cell carcinoma (WHO type I).
• • 2. Received systemic or local glucocorticoid therapy within 4 weeks before enrollment.
• • 3. Patients who have participated in other drug clinical trials within 3 months before treatment.
• • 4. Patients with a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 5. Idiopathic pulmonary fibrosis, drug-induced pneumonia, institutional pneumonia (i.e., bronchiolitis obliterans), clinical symptoms or Radiation pneumonia, active pneumonia, or other moderate to severe lung disease requiring steroid treatment 6. Have a comorbiditis that requires prolonged treatment with immunosuppressive drugs or systemic or local use of immunosuppressive doses of corticosteroids.
• • 7. The subject has any active autoimmune disease or history of autoimmune disease (including, but not limited to, interstitial disease) Pneumonia, uveitis, enteritis, hepatitis, pituitaritis, nephritis, hyperthyroidism, hypothyroidism; Suffer from Patients with vitiligo or asthma that had completely resolved in childhood and did not require any intervention in adulthood were included; Need bronchus Dilators for medical intervention in asthma were not included).
• • 8. Positive HBV DNA copy number was detected in both HIV-positive and HBsAg positive patients (quantitative detection ≥ 1000cps/ml); Chronic hepatitis C blood screening positive (HCV antibody positive) with HCV RNA positive detection.
• • 9. Received any anti-infection vaccine (such as influenza vaccine, chickenpox vaccine, etc.) within 4 weeks before enrollment.
• • 10. Pregnancy test positive women of childbearing age and breastfeeding women. 11. Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographical reasons.