nasopharyngeal carcinoma
Conditions
Interventions
Experimental group:Immunotherapy combined with chemotherapy followed by radiotherapy after remission
Sponsors
Guangzhou Medical University Affiliated Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The diagnosis of nasopharyngeal carcinoma is confirmed by histopathological or cytological examination. 2. According to the standard of UICC/AJCC TNM Version 8, the clinical stage of nasopharyngeal carcinoma was defined as T1-4N0-3M1, i.e., stage IVB nasopharyngeal carcinoma. 3. I have not received any anticancer treatment in the past. 4. Aged from 18 to 65 years old and KPS=70 points. 5. Patients with complete or partial remission (CR) confirmed by imaging after 6 cycles of GP regimen combined with PD-1 medication. 6. Vital organ function is good before radiotherapy: bone marrow, heart, liver, kidney and nervous system function are basically normal: meet the following laboratory parameters 1) Peripheral hemogram: WBC = 3.0× 10 9/L, ANC = 15× 10 9/L, PLT = 100× 10 9/L, and HGB = 60 g/L; 2) Renal function: serum creatinine = 1.5*ULN or calculated creatinine clearance (CrCl)> 60 mL/min (Appendix Cockcroft Gault formula); 3) Liver function: ALT, AST, TBIL = 1.5 * ULN; ALT and/or AST = 5 × ULN, if liver metastasis is present; If there is liver metastasis or bone metastasis, AKP = 5 × ULN; 7. Sign the informed consent for treatment; Follow-up with regular pattern; Able to follow the requirements of the experiment. If either of the above answers No, the subject will not be eligible for participation in the study.
Exclusion criteria
Exclusion criteria: 1. Has received chemoradiotherapy or surgery for nasopharyngeal carcinoma in the past 2. Other tumors are combined; KPS score Class 2 NCI-CTC V5.0). 7. Has a history of immunodeficiency disease; History of non-infectious pneumonia. 8. A history of active autoimmune diseases or autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism and hypothyroidism, including but not limited to these diseases or syndromes); Autoimmune-mediated hypothyroidism excluding treatment with a stable dose of thyroid replacement hormone; Type I diabetes using a stable dose of insulin; Cured vitiligo or childhood asthma/allergy in adulthood without any intervention. 9. Pregnant or nursing patients. Female patients with a potential pregnancy must have a negative pregnancy test within 7 days of the start of treatment to continue. Patients enrolled in the trial must use contraception during the trial until two weeks after completion of the trial 10. The patient refuses to participate, or has personality or mental illness, or has no capacity for civil conduct or limited capacity for civil conduct If YES to any of the above, the subject will not be eligible for participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;overall survival;Duration of Response;Safety and Survivability; | — |
Countries
China
Contacts
Public ContactMingyi Li
Outcome results
None listed