Nasopharyngeal Carcinoma
Conditions
Interventions
Test group:Iparomlimab and Tuvonralimab combined with GP
Sponsors
First Affiliated Hospital of Sun Yat-sen university
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 65 years old; 2. Pathologically diagnosed non-keratinizing nasopharyngeal carcinoma; 3. Staged as III-IVa according to the 8th edition of the UICC/AJCC staging system (excluding T3-4N0-1) (see Appendix I); 4. No distant metastasis; 5. No prior anti-tumor treatment received; 6. Eastern Cooperative Oncology Group (ECOG) performance status score: 0-1 (see Appendix II); 7. Blood routine, liver and kidney function, and coagulation function meet the following conditions: 1) Neutrophil count >= 1.5×10?/L; 2) Platelet count >= 100×10?/L; 3) Hemoglobin concentration >= 90g/L; 4) Serum albumin concentration >= 30g/L; 5) Total bilirubin 60 mL/min; 8) Activated partial thromboplastin time (APTT) and international normalized ratio (INR) <= 1.5 times the upper limit of normal (for those receiving stable-dose anticoagulant therapy such as low-molecular-weight heparin or warfarin and with INR within the expected therapeutic range of the anticoagulant, they can be screened).
Exclusion criteria
Exclusion criteria: 1. Receive treatment for the purpose of palliative care; 2. Have other concurrent malignant tumors; 3. Have a history of previous malignant tumors; 4. Have previously received immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.) or any treatment targeting the immunological mechanism of tumors, including those targeting immune costimulatory factors (such as antibodies targeting ICOS, CD40, CD137, GITR, OX40 targets, etc.). 5. Subjects who require systemic treatment with glucocorticoids (> 10 mg/day of prednisone or equivalent glucocorticoids) or other immunosuppressive drugs within 2 weeks before randomization; the following are excluded: 1) Inhaled, ophthalmic or topical treatment with glucocorticoids at a dose = II; 2) Have severe arrhythmias that require long-term drug intervention; asymptomatic patients with atrial fibrillation and stable ventricular rate are permitted to be enrolled; 3) Have had a cerebrovascular accident (CVA) within 6 months before randomization; 4) Left ventricular ejection fraction (LVEF) 1000 IU/mL, and subjects with active hepatitis C virus infection. Note: Inactive or asymptomatic carriers, and subjects with hepatitis B who have been treated and are stable with HBV DNA <= 1000 IU/mL are allowed to be enrolled. Subjects with cured hepatitis C virus infection, who are positive for HCVAb and negative for HCVRNA, are allowed to be enrolled. 14. Have active or documented inflammatory bowel disease (such as Crohn's disease, ulcerative colitis), active diverticulitis. 15. Have a known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 16. Have a known history of severe hypersensitivit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety; | — |
Countries
China
Contacts
Public ContactYong Chen
First Affiliated Hospital of Sun Yat-sen university
Outcome results
None listed