nasopharyngeal carcinoma
Conditions
Interventions
Experimental group :cadonilimab +induction chemotherapy+ Concurrent chemoradiotherapy
Control group :placebo+induction chemotherapy+ Concurrent chemoradiotherapy
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate and sign the informed consent in writing. 2. Aged 18-70 years (when signing the informed consent form for the study), gender is not limited. 3. Patients with non-keratinizing squamous cell nasopharyngeal carcinoma confirmed by pathology or histology, tumor stage is (T1-2N2-3/T3-4N0-3M0)stage III-IVa(according to AJCC 8th edition). 4. Patients must have disease measurable by CT or MRI according to RECIST 1.1 criteria. 5. Not treated with radiotherapy, chemotherapy, immunotherapy or biological therapy. 6. There are no contraindications for immunotherapy or radiotherapy or chemotherapy. 7. Tumor tissue can be provided for PD-1 expression detection: Newly obtained biopsy (within 90 days before the start of study treatment) is preferred. If biopsy tissue cannot be provided for detection, archived tissue wax blocks can be provided for post-section detection. 8. PD-1 Combined Positive Score (CPS) >= 1. 9. Karnofsky scale (KPS) >=70. 10. Female patients of childbearing age should have negative serum or urine pregnancy within 72 hours before receiving the first dose of study drug; negative urine pregnancy test (female), and take contraceptive measures during the test period to 3 months after the end of the test. 11. Hemoglobin (HGB)>=90 g/L, white blood cell (WBC)>=4x10^9/L, platelet (PLT)>=90x10^9/L (No blood transfusion and blood products within 14 days, no correction with G-CSF and other hematopoietic stimulating factors). 12. Liver function: alanine aminotransferase (ALT) and or aspartate aminotransferase (AST) <1.5 times the upper limit of normal (ULN); total bilirubin (TBIL) <1.5 times the upper limit of normal (ULN). 13. Renal function: serum creatinine <1.5 times the upper limit of normal (ULN); creatinine clearance rate not less than 60ml/min. 14. Good coagulation function: defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; if the patient is receiving anticoagulation therapy, as long as the PT is within the intended range of anticoagulation drugs . 15. Myocardial markers are within the normal range; thyroid function is within the normal range. 16. According to the judgment of the investigator, the patient is considered to be able to comply with the protocol.
Exclusion criteria
Exclusion criteria: 1. Sybjects who previously received immunotherapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibodies or any other antibodies and drugs targeting T cell costimulation or immune checkpoint pathway. 2. Subjects who have received other drug trials in the past 1 month. 3. Known hypersensitivity to macromolecular protein products or any investigational therapeutic compound, or to any component of investigational drug or preparation that has caused severe hypersensitivity reactions, including severe hypersensitivity reactions to other monoclonal antibody-related compounds (NCI CTCAEv5.0 >= grade 3). 4. Those with severe allergic history or idiosyncratic constitution. 5. The subject is known to have other malignant tumors. 6. Pre-existing peripheral neuropathy grade >=2 according to the criteria of Common Adverse Event Terminology (NCI CTCAEv5.0). 7. Interstitial lung disease or non-infectious pneumonia (including past medical history and current disease); except for local interstitial pneumonia induced by radiotherapy. 8. Suffering from uncontrolled systemic diseases, including diabetes, hypertension, acute lung disease, etc. 9. Active infection requiring systemic treatment, including active tuberculosis. 10. There are obvious cardiovascular diseases, such as heart failure with grade 2 and above by the American New York Heart Association (NYHA), myocardial infarction within the past 3 months, unstable arrhythmia (including QT interval >=480 ms) or unstable angina. 11.Active hepatitis B or C, conforming to any one of the following: HBsAg positive, and peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) titer test >=1x10^3 copies/L; positive for HCV antibodies and positive for HCV-RNA (results greater than the detection limit of the assay). 12. A history of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation. 13. Active autoimmune disease that may worsen when receiving systemic steroid therapy or any other form of immunosuppressive therapy, receiving immunostimulatory agents (Except for subjects with type 1 diabetes mellitus, vitiligo, psoriasis, or hypo or hyperthyroid disease that do not require immunosuppressive therapy). 14. Subjects had major surgery within 4 weeks prior to the first day of the study, or had an unhealed wound, ulcer, or fracture. 15. The subject has received live virus vaccine within 4 weeks before the first day of the study (seasonal influenza vaccine and new crown vaccine without live virus are allowed). 16. Received antibiotic treatment within the first 4 weeks of the first dose of study drug. 17. Known substance abuse or psychiatric subject with severe intellectual or cognitive impairment that interferes with cooperation with trial requirements. 18. Breastfeeding, or expecting pregnancy or childbearing during the trial period, from the screening visit to 180 days after the last dose of study drug. 19. Those who refuse or cannot sign the informed consent form. 20. Patients who can't comply with the trial plan or cooperate with the 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;Safety evaluation;Tumor mutation burden;PD-L1 expression;Plasma EB virus DNA copy number;Genetic biomarkers of gut microbes; | — |
Countries
China
Contacts
Public ContactWang Weidong
Sichuan Cancer Hospital
Outcome results
None listed