Locally advanced nasopharyngeal cancer
Conditions
Interventions
Intervention group:(1) If the patient experiences disease progression, they will enter concurrent radiochemotherapy combined with immunotherapy: IMRT + cisplatin (100 mg/m2, q3w, for a total of 3 cycl
Sponsors
Jingmen Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Age = 18 years, = 70 years. (2) Pathologically confirmed "non-keratinizing (WHO standard type 2 and 3)" untreated nasopharyngeal carcinoma. (3) ECOG performance status (PS) score 0 or 1. (4) Male or female aged = 18 years and = 70 years on the date of signing the informed consent form. (5) Locally regional advanced nasopharyngeal cancer (stage III-IVa) diagnosed according to the American Joint Committee on Cancer's eighth edition clinical staging system; (6) Neutrophil count = 1.5 × 109/L, haemoglobin =90g/L, and platelet count =100 × 109/L. (7)Alanine aminotransferase (GPT)/aspartate aminotransferase (Glutamic-oxaloacetic transferase) = 2.5 times the upper limit of normal (ULN), Bilirubin = 1.5 times ULN. Creatinine clearance = 60 ml/min (calculated according to Cockcroft-Gault formula) (8)Life expectancy = 6 months. (9)The patient must sign the informed consent form and must be willing and able to comply with the visits, treatment regimen, Laboratory tests and other Investigations specified in the study protocol. (10)Females of childbearing potential must agree to use reliable Contraception measures (e.g., Condom, regular The pill as directed by the doctor) from screening to 1 year after treatment.
Exclusion criteria
Exclusion criteria: 1) Positive for hepatitis B surface antigen and quantification of hepatitis B virus >1×103 copies/mL; (2) HCV Antibody positive. (3) Active, known or suspected autoimmune disease, except subjects with Type I diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, skin diseases (such as vitiligo, psoriasis or alopecia) that do not require systemic treatment. (4) History of interstitial lung disease or pneumonia requiring oral or intravenous steroid therapy within the previous year; (5) Received equivalent doses >10 mg prednisone/day of systemic steroids or other immunosuppressive therapy within 28 days prior to signing the informed consent document. Excluded are subjects who received systemic steroids doses =10 mg prednisone/day or inhaled/topical corticosteroids. (6) Received a live vaccine within 30 days prior to signing the informed consent document. (7) Pregnant or lactating women. (8) Other malignancies diagnosed within 5 years, except carcinoma in situ, adequately treated non-melanoma skin cancer and papillary thyroid cancer. (9) Known history of allergy to macromolecular protein preparations or any components of toripalimab. (10) Human immunodeficiency virus (HIV infection). (11) Other conditions as judged by the investigator that may affect subject safety and compliance with the trial protocol. This includes symptomatic cardiac failure, unstable angina pectoris, myocardial infarction, active infection requiring systemic treatment and mental illness. Family and social factors will also be considered.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Countries
China
Contacts
Public ContactZhang Qinhua
Jingmen Central Hospital
Outcome results
None listed