Locally Advanced Nasopharyngeal Carcinoma
Conditions
Interventions
Experimental group:Neoadjuvant Tislelizumab-Nivolumab-GP followed by concurrent Tislelizumab-Nivolumab-IMRT and maintenance Tislelizumab
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.The subjects have consented to and signed the informed consent form, willingly and capable of complying with the planned visits, research treatments, laboratory tests, and other trial procedures. 2.The subjects are between the ages of 18 and 75 (inclusive), and both males and females are eligible. 3.Pathologically or cytologically confirmed nasopharyngeal carcinoma patients with positive EGFR expression. 4.Disease staging should be T3-4N2-3M0 (8th edition AJCC/UICC staging). 5.Presence of measurable lesions that meet the response evaluation criteria in solid tumors (RECIST version 1.1) requirements. 6.No prior systemic treatment for nasopharyngeal carcinoma (including chemotherapy, EGFR inhibitors, anti-PD-1 or PD-L1 antibodies, anti-CTLA-4 antibodies, and other immune checkpoint inhibitors). 7.Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1. 8.Adequate organ function based on laboratory values obtained during the screening period: white blood cell count = 3×109/L, neutrophil count = 1.5×109/L, platelet count = 75×109/L, serum total bilirubin = 1.5× upper limit of normal (ULN), aspartate aminotransferase or alanine aminotransferase = 2.5×ULN (= 5×ULN for patients with liver metastasis), serum creatinine = 1.5×ULN. 9.Pre-menopausal female participants must have a negative serum pregnancy test within 3 days before starting the study medication and agree to use a medically accepted highly effective method of contraception during the study and for 3 months after the last dose of the study drug (such as intrauterine devices, contraceptive pills, or condoms). Male participants with female partners of childbearing potential should also agree to use an effective method of contraception during the study and for 3 months after the last dose of the study drug.
Exclusion criteria
Exclusion criteria: 1.History of current or concurrent active malignancy (excluding malignancies treated with curative intent and disease-free for more than 5 years or adequately treated in situ carcinomas). 2.Active bleeding within the past 3 months or occurrence of thrombotic events (arterial or venous) within the past 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, or pulmonary embolism; known hereditary or acquired bleeding disorders (e.g., coagulation disorders) or thrombotic predisposition, such as patients with hemophilia; currently or recently (within 10 days prior to the start of study treatment) received full-dose oral or parenteral anticoagulant or thrombolytic agents for therapeutic purposes (prophylactic use of low-dose aspirin or low-molecular-weight heparin is allowed); major surgery (excluding biopsy) within 4 weeks prior to initiation of the study drug treatment or incomplete wound healing of surgical incision. 3.Use of systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to treatment initiation, with anticipated or planned use of systemic immunosuppressive medications during the trial. Use of inhaled corticosteroids or physiological replacement doses of corticosteroids is allowed. 4.History of autoimmune diseases. 5.Known active tuberculosis, receiving anti-tuberculosis treatment, or received anti-tuberculosis treatment within 1 year prior to the first dose of study medication. 6.Severe, uncontrolled systemic diseases, such as severe active infections. 7.Known human immunodeficiency virus (HIV) infection or known positive HIV serum. 8.Untreated chronic hepatitis B or carrier of hepatitis B virus (HBV) (HBV DNA > 500 IU/mL) or active carrier of hepatitis C virus (HCV) with detectable HCV RNA. Note: Inactive carriers of hepatitis B surface antigen (HBsAg) or patients with chronic hepatitis B receiving stable treatment (HBV DNA < 500 IU/mL) can be enrolled. 9.History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis, or symptomatic interstitial lung disease, or active pneumonia detected by chest CT scan within 4 weeks prior to initiation of the study drug treatment. 10.Known symptomatic, untreated, or progressively growing central nervous system (CNS) or leptomeningeal metastases. 11.Known allergy to any study drug or excipient. 12.Participation in another drug clinical trial within 4 weeks prior to enrollment. 13.Breastfeeding females.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Response Rate, CR Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR;Locally Relapse-Free Survival, LFRS;Distant Metastasis-Free Survial, DMFS;Overall Survial, OS;Safety; | — |
Countries
China
Contacts
Public ContactSufang Qiu
Fujian Cancer Hospital
Outcome results
None listed