nasopharyngeal carcinoma
Conditions
Interventions
experimental group:Induction chemotherapy with teriprizumab plus nituzumab and GP followed by radical radiotherapy
control group:Induction chemotherapy with nituzumab and GP followed by chemoradiotherapy
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years. 2. Carlisle score >70. 3. Life expectancy is at least six months. 4. Stage III patients with pre-treatment plasma EBV-DNA concentration >=1500 copies/ml and stage IVa, non-N0 patients. 5. Immunohistochemistry: EGFR positive. 6. Subject has at least one measurable lesion (tumor lesion located in the original radiotherapy-exposed area is not selected as measurable lesion). 7. The following laboratory tests were performed to evaluate bone marrow, liver and kidney function within the first 7 days of screening: (1) Hemoglobin > 10.0g /dl; (2) White blood cell count (ANC) >4000/mm^3; (3) Platelet count > 100,000/µL; (4) Total bilirubin <= 1.5 times the upper limit of normal value (ULN); (5) Alanine aminotransferase and aspartate aminotransferase < 1.5ULN (upper limit of normal value); (6) Prothrombin time (PT) international normalized ratio/prothrombin time (PTT) < 1.5ULN, serum creatinine < 1.5ULN. 8. Subject shall sign and date the informed consent form before performing any procedure required by the protocol.
Exclusion criteria
Exclusion criteria: 1. Evidence of distant transfer. 2. The primary tumor or lymph node has been treated with surgery (except biopsy). 3. Patients with primary lesion or lymph node receiving radiotherapy. 4. Patients who have received epidermal growth factor targeted therapy. 5. Have received chemotherapy or immunotherapy. 6. History of other malignancies (other than non-melanocyte skin cancer or carcinoma in situ of the cervix). 7. Patients with autoimmune diseases. 8. Patients who have received other drug trials within the last 1 month. 9. > grade I peripheral neuropathy. 10. Pregnant or lactating patients and patients of childbearing age who refuse contraception during the treatment observation period. 11. Patients with severe allergic history or special constitution. 12. Patients with a history of severe lung or heart disease. 13. Refusal or inability to sign informed consent. 14. Drug or alcohol addicts. 15. Patients with personality or mental disorders, without or with limited capacity for civil conduct.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;3-year overall survival;5-year overall survival; | — |
Primary
| Measure | Time frame |
|---|---|
| 2-year progression free survival; | — |
Countries
China
Contacts
Public ContactXiang Yanqun
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Outcome results
None listed