Nasopharyngeal Carcinoma
Conditions
Interventions
Control group:Cisplatin 100 mg/m^2, intravenous infusion, d1
21 days is 1 cycle, a total of 2 cycles.
placebo 240 mg intravenously (at least 60 minutes for the first time, can be shortened to 30 minutes for the second time), d1
21 days for 1 cycle
Take the drug up to 17 cycles or 1 year.
Experimental group:Cisplatin 100 mg/m^2, intravenous infusion, d1
21 days is 1 cycle, a total of 2 cycles.
toripalimab 240 mg intravenously (at least 60 minutes for the first time, shortened to 30 minutes for the second time), d1
Take the drug up to 17 cycles or 1 year
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 18~70 years old; 2. Pathologically confirmed WHO type II or III. nasopharyngeal carcinoma; 3. AJCC/UICC 8th Edition stage II~IVA before induction chemotherapy; 4. After the completion of induction chemotherapy, the efficacy evaluation SD/PD, or the serum EBV-DNA test is positive; 5. Performance status score of 0 or 1 according to Eastern Cooperative Oncology Group (ECOG) criteria (Appendix 1); 6. Female subjects of childbearing potential, with a negative serum pregnancy test at screening (within 7 days prior to the first dose of study drug), and adequate contraceptive measures from before entering the study and throughout the study period until 6 months after the last dose of the study drug; 7. No serious dysfunction of important organs such as heart, lung, liver, kidney, etc.; 8. Normal liver and kidney function: AST, ALT =60 mL/min; Adequate bone marrow function: peripheral blood leukocyte > 4.0×10^9/L, neutrophil > 2.0×10^9/L, hemoglobin > 90 g/L, platelet > 100×10^9/L; 9. Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Distant metastasis or negative serum EBV-DNA test in the efficacy evaluation after induction chemotherapy; 2. With a second tumor; 3. Previous history of hypersensitivity to other monoclonal antibodies or any component of toripalimab; 4. Prior treatment against PD-1 receptor or its ligand PD-L1 or cytotoxic T lymphocyte-associated protein 4 (CTLA4) receptor; 5. Use of anti-tumor traditional herbal medicines within 4 weeks prior to the start of the study protocol, or undergo major surgery or have a history of severe trauma; 6. History of autoimmune disease, the following two conditions can be evaluated for participation: (1) patients with autoimmune-related hypothyroidism receiving stable dose thyroid hormone replacement therapy; (2) patients with type 1 diabetes mellitus were controlled after receiving a stable insulin regimen; 7. Treatment with systemic immunostimulatory drugs (including but not limited to interferon or IL-2) within 4 weeks of the start of the study protocol or within 5 half-lives of the drug (whichever is shorter); 8. Receipt of systemic corticosteroids (>10 mg/d prednisone equivalent) or other systemic immunosuppressants within 2 weeks of the start of the study protocol. Corticosteroids may be used topically or inhaled; 9. Patients who have undergone prior bone marrow transplantation or organ transplantation; 10. History of idiopathic pulmonary fibrosis, drug-induced pneumonia, organizing pneumonitis, idiopathic pneumonitis, or other active pneumonitis; 11. Administration of any live vaccine within 4 weeks prior to the start of the study protocol; 12. Active infection, including tuberculosis, hepatitis B (HBsAg positive), hepatitis C, or human immunodeficiency virus (HIV antibody positive); 13. Having psychiatric or other underlying diseases that cannot be treated in accordance with the treatment; 14. Pregnant or lactating female patients; 15. Major cardiovascular disease: NYHA grade II or above, patients with myocardial infarction within 1 year, unstable angina, supraventricular tachycardia or ventricular arrhythmia requiring clinical intervention, etc. 16. Inability to cooperate with regular follow-up due to psychological, social, familial and geographical reasons; 17. Concomitant severe uncontrollable infection or medical disease; 18. Major organ dysfunction, such as decompensated heart, lung, kidney, and liver failure, unable to tolerate chemotherapy; 19. Laboratory tests: total bilirubin > 1.5 times the upper limit of normal (ULN), AST and/or ALT > 2.5 times the upper limit of normal (ULN) with alkaline phosphatase >2.5 times the upper limit of normal (ULN); 20. Factors affecting administration, distribution, metabolism, excretion, etc., such as mental abnormalities, central nervous system abnormalities, chronic diarrhea, ascites, pleural effusion, etc.; 21. Previous or concurrent other malignant tumors (except for malignant tumors that have been cured and have survived without cancer for more than 5 years, such as basal cell carcinoma of the skin, carcinoma in situ of the cervix, etc.); 22. Does not agree to sign an informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Safety Assessment;distant metastasis-free survival;Locoregional relapse-free survival;Quality of life; | — |
Countries
China
Contacts
Public ContactLv Xing
Sun Yat-Sen University Cancer Center
Outcome results
None listed