Nasopharyngeal carcinoma
Conditions
Interventions
Control group:cisplain
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. pathologically confirmed differentiated non-keratinized carcinoma or undifferentiated non-keratinized carcinoma; 2. AJCC 8th edition is phase II-IVa (except N3); 3. EBV DNA copies = 4,000 copies/ml; 4. patients who have not received anti-tumor treatment for the first time; 5. no history of other malignant tumors; 6. male or female, aged 18-65 years; 7. adequate liver function: total bilirubin = 2 times the upper limit of normal (ULN); AST and ALT = 2.5 times the upper limit of normal (ULN); 8. adequate renal function: creatinine clearance rate = 60 mL / min; 9. adequate blood function: absolute neutrophil count (ANC) = 2×10^9/L, platelet count = 100×10^9/L and hemoglobin = 9g/dL; 10. No serious heart, lung and other vital organ dysfunction; 11. PS score = 2 points.
Exclusion criteria
Exclusion criteria: 1. has been treated with anti-tumor, including chemotherapy, radiotherapy, surgery; 2. distant metastasis was found before treatment; 3. women who are pregnant or breastfeeding; 4. Disagree to sign the informed consent form; 5. patients who are unable to cooperate with regular follow-up due to psychological, social, family and geographical reasons; 6. also receive experimental treatment of other clinical studies (in the treatment period of clinical research); 7. known to be allergic to possible chemotherapeutic drugs; 8. with serious uncontrollable infections or medical diseases; 9. major organ dysfunction, such as decompensated heart, lung, kidney, liver failure, can not tolerate radiotherapy and chemotherapy; 10. Laboratory tests: total bilirubin > 2 times the upper limit of normal (ULN); AST and / or ALT > 2. times the upper limit of normal (ULN); 11. factors affecting drug delivery, distribution, metabolism, excretion, etc., such as mental disorders, central nervous system abnormalities, chronic diarrhea, ascites, pleural effusion, etc.; 12. long-term use of immunosuppressants after organ transplantation; 13. There were other history of malignant tumors before enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-years progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and adverse events;overall survival;Objective response rate (ORR);;local recurrence free survival (LRRFS);;distance metastatic free survival; | — |
Countries
China
Contacts
Public ContactYanqun Xiang
Sun Yat-Sen University Cancer Center
Outcome results
None listed