Nasopharyngeal carcinoma
Conditions
Interventions
experimental group:Radiotherapy+Treprizumab
Sponsors
Medical Ethics Committee of Jiangxi Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age is greater than or equal to 70 years old; 2) ECOG score 0-1; 3) WHO type II/III newly treated nasopharyngeal carcinoma confirmed by histology/cytology; 4) The 8th edition of AJCC is staged for patients with stage III-IVA; 5) No other important related diseases (such as other tumors, serious heart, lung and central nervous system diseases, etc.); 6) Routine blood HB >= 90g/L; ANC >= 1.5 x 10^9/L; PLT >= 80 x 10^9/L; 7) The biochemical examination meets the following standards: BIL = 50ml/min (Cockcroft-Gault formula); 8) Survival period >= 12 months; 9) No previous allergic reactions to biological agents are expected; 10) No bad habits such as drug abuse; 11) Those who are expected to have good compliance; 12) Participate voluntarily and sign written informed consent.
Exclusion criteria
Exclusion criteria: 1) The patient has distant metastases; 2) Patients with 2 or more tumors at the same time; 3) The patient has previously received radiotherapy or chemotherapy for the head and neck; 4) Subjects who need to be given corticosteroids (>10 mg prednisone equivalent dose per day) or other immunosuppressive agents for systemic treatment within 2 weeks before the first use of the study drug; 5) Patients with severe allergies or allergies; active autoimmune diseases that may worsen when receiving immunostimulants. Patients with type I diabetes, vitiligo, psoriasis, or hypothyroidism or hyperthyroidism diseases that do not require immunosuppressive treatment are eligible to participate in the study; 6) Immunodeficiency or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related diseases, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (HBV surface antigen positive, or HCV RNA is positive when the anti-HCV antibody screening test is positive). Have a known history of active tuberculosis (TB); 7) Uncontrollable clinical symptoms or diseases of the heart, such as: NYHA II or higher heart failure, unstable angina, myocardial infarction within 1 year, clinically significant supraventricular or ventricular arrhythmia patients who require clinical intervention 8) Severe infections (CTCAE > Grade 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infection comorbidities that require hospitalization, etc.; baseline chest imaging examinations suggest the presence of active lung inflammation Symptoms and signs of infection within 2 weeks before the first use of the study drug or need to be treated with oral or intravenous antibiotics (excluding prophylactic antibiotics); 9) The investigator believes that it is not appropriate to participate in this trial, such as severe acute or chronic medical conditions (including immune colitis, inflammatory bowel disease, non-infectious pneumonia, pulmonary fibrosis) or mental illness (including recent or active suicide) Ideas or behavior) or abnormal laboratory tests.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival, PFS; | — |
Countries
China
Contacts
Public ContactJingao Li, Ziwei Tu
Jiangxi Cancer Hospital
Outcome results
None listed