nasopharyngeal carcinoma
Conditions
Interventions
Experimental group:2 cycles of induction chemotherapy + 3 cycles of synchronous chemotherapy + 7 cycles of tiriplizumab immunotherapy
Control group:2 cycles of induction chemotherapy + 3 cycles of synchronous chemotherapy + 7 cycles of placebo
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in and sign the informed consent in person. 2. Age 18-70 years (at the time of signing the informed consent for the study), regardless of gender. 3. Patients with nasopharyngeal carcinoma diagnosed by pathology or histology with tumor stage (T1-2N2-3/T3-4N0-3M0), III-IVa (according to AJCC 8th Edition). 4. According to RECIST 1.1 criteria, the subject must have a disease that can be measured by CT or MRI. 5. No treatment such as radiotherapy, chemotherapy, immunotherapy or biotherapy has been given. 6. No contraindications for immunotherapy or radiotherapy or chemotherapy 7. Tumor tissue can be provided for PD-L1 expression detection: Newly obtained biopsy (within 90 days before the start of the study treatment) is preferred; if biopsy tissue is not available for detection, archived tissue wax blocks can be provided for post-section detection. 8. Karnofsky scale (KPS) =70. 9. A female patient of reproductive age who has a negative serum or urine pregnancy within 72 hours before receiving the first dose of the study drug; Urine pregnancy tests were negative (women) and contraception was used during the trial period to 3 months after the end of the trial. 10. Hemoglobin (HGB)=90 g/L, white blood cells (WBC)=4×10^9 /L, platelets (PLT)=90×10^9 /L (no blood transfusion and blood products within 14 days, no G-CSF and other hematopoietic stimulating factors were used to correct). 11. Liver function: alanine aminotransferase (ALT) and or aspartate aminotransferase (AST) <1.5 times upper limit of normal (ULN); Total bilirubin (TBIL) was less than 1.5 times the upper limit of normal (ULN). 12. Renal function: serum creatinine <1.5 times the upper limit of normal (ULN); Creatinine clearance is not less than 60ml/min. 13. Good coagulation function: defined as International standardized ratio (INR) or prothrombin time (PT) =1.5 times ULN; If the subject is receiving anticoagulant therapy, PT should be within the intended range of anticoagulant use. 14. Myocardial markers were within the normal range; Thyroid function is within the normal range. 15.The investigators judged that the patients could comply with the protocol.
Exclusion criteria
Exclusion criteria: 1. Previous immunotherapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies or any other antibody or drug that targets T-cell co-stimulation or immune checkpoint pathways. 2. Subjects who have received other drug trials within the last 1 month. 3. A known allergy to a macromolecular protein product or any investigational therapeutic compound, or any component of an investigational drug or formulation that has ever caused a severe hypersensitivity reaction, including a severe hypersensitivity reaction to other monoclonal antibody associated compounds (NCI CTCAEv5.0 =3). 4. People with severe allergies or idiosyncrasies. 5. The subject is known to have other malignancies. 6. According to the Common Adverse Event terminology (NCI CTCAEv5.0) criteria, peripheral neuropathy = grade 2 was present. 7. Interstitial lung disease or noncommunicable pneumonia (including pre-existing and current disease); Except for local interstitial pneumonia induced by radiotherapy. 8. Have uncontrolled systemic diseases, including diabetes, high blood pressure, acute lung disease, etc. 9. Active infections requiring systemic treatment, including active tuberculosis. 10. Have significant cardiovascular disease, such as New York Heart Association (NYHA) grade 2 or higher heart failure, previous myocardial infarction within 3 months, unstable arrhythmias (including QT interval =480 ms), or unstable angina pectoris. 11. Active hepatitis B or C, meeting any of the following criteria: HBsAg positive, and peripheral blood HBV DNA titer =1x10^3 copies/L; HCV antibody positive and HCV-RNA positive (results greater than the lower limit of assay). 12. People with a history of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation. 13. Active autoimmune diseases that may worsen when receiving systemic steroid therapy or any other form of immunosuppressive therapy (except for patients with type I diabetes, vitiligo, psoriasis, or hypothyroidism or hyperthyroidism that do not require immunosuppressive therapy). 14. Patients had undergone major surgery or had unhealed wounds, ulcers, or fractures within 4 weeks prior to the first day of the study. 15. Patients received live virus vaccine (seasonal influenza vaccine and COVID-19 vaccine without live virus are allowed) within 4 weeks prior to the first day of the study. 16. Antibiotics were received within the first 4 weeks of the first dose of the study drug. 17. Patients with known substance abuse or psychiatric disorders have severe intellectual or cognitive impairments that interfere with cooperation with trial requirements. 18. Pregnancy, lactation, or expected pregnancy or birth during the trial period, from the beginning of the screening visit to 180 days after the last dose of the study drug. 19. Those who refuse or cannot sign informed consent. 20. Patients who are unable to follow the trial protocol or fail to cooperate with follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Objective Response Rate;Disease Control Rate;Duration of Response;Disease Free Survival;Overall Survival;Distance Metastasis Free Survival;Locoregional Relapse-Free Survival;Quality of Life; | — |
Countries
China
Contacts
Public ContactWang Weidong
Sichuan Cancer Hospital
Outcome results
None listed