nasopharyngeal carcinoma
Conditions
Interventions
Experimental group:radiotherapy combined with Zimberelimab
Sponsors
Second Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Voluntarily participate and sign the informed consent in writing. (2) Age = 18 years old, gender is not limited. (3) Pathologically diagnosed non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated, that is, WHO type II or III) and stage III-IVa nasopharyngeal carcinoma. (8th AJCC/UICC stage) (4) Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1. (5) Female subjects of childbearing age must agree to take effective contraceptive measures after signing the informed consent form, during the study and within 5 months after the last dose. (6) Hemoglobin (HGB) =90g/L, white blood cell (WBC) =4×109/L, platelet (PLT) =100×109/L. (7) Liver function: ALT, AST<2.5 times the upper limit of normal (ULN), total bilirubin<1.5×ULN, serum albumin=28g/L. (8) Renal function: serum creatinine <1.5×ULN or calculated value of creatinine clearance (CrCl) =50mL/min (Cockcroft-Gault formula). (9) Thyroid-stimulating hormone (TSH) = 1×ULN (if abnormal, the levels of FT3 and FT4 should be investigated at the same time, if the levels of FT3 and FT4 are normal, they can be enrolled). (10)International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) = 1.5 x ULN (unless the subject is receiving anticoagulant therapy and coagulation parameters (PT/IN and APTT) at screening are on anticoagulation within the expected range of drug therapy).
Exclusion criteria
Exclusion criteria: (1) Patients with nasopharyngeal carcinoma who have received radiotherapy or chemotherapy. (2) Women who are pregnant or breastfeeding. (3) Have used anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody or anti-lymphocyte antigen 4 (CTLA-4) antibody therapy (including ipilimumab or specific T cells any other antibodies or drugs that co-stimulate or checkpoint pathways). (4) The patient has any active autoimmune disease or has a history of autoimmune disease. (5) Subjects who require systemic treatment with corticosteroids (>10mg/day equivalent dose of prednisone) or other immunosuppressive drugs within 14 days before the administration of the study drug. (6) Any conditions that the investigator considers may lead to the risk of receiving the study drug treatment or will interfere with the evaluation of the study drug or the safety of the subjects or the interpretation of the study results. (7)Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation or planning to undergo transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free of Survival;Overall survival; Locoregional Relapse-Free Survival;Distant metastases-Free Survival;Safety; | — |
Countries
China
Contacts
Public ContactXiaoyong REN
Second Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed