nasopharygeal carcinoma
Conditions
Interventions
Experimental group:Neoadjuvant chemotherapy plus camrelizumab and concurrent chemoradiotherapy
Sponsors
Hui Zhou Municipal Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed nasopharyngeal nonkeratinizing undifferentiated carcinoma with EGFR expression ( +); 2) Presence of measurable lesions according to RECIST 1.1 criteria; 3) Judged by the investigator: locally advanced (stage III/IVA) nasopharyngeal carcinoma, which needs to be treated with induction chemotherapy and concurrent chemoradiotherapy (combined with nimotuzumab), naïve treatment, and patients without distant metastases are evaluated; 4) Age 18-65 years old, male or female;; 5) ECOG physical status score is 0~1; 6) No previous head and neck radiotherapy, immunotherapy, or targeted therapy; 7) Serum hemoglobin >= 100g/L, platelet >= 100×10^9/L, absolute neutrophil count >= 1.5×10^9/L; 8) Serum creatinine = 60 mL/min; 9) Serum bilirubin 1.0 L; 11) Normal coagulation function (no more than 3 seconds for PT and no more than 10 seconds for APTT; 12) Thyroid function: thyroid-stimulating hormone (TSH) within the range of ±10% of the normal value (if abnormal, T3 and T4 levels should be investigated at the same time, if the levels of T3 and T4 are normal, they can be enrolled), patients with hypothyroidism controlled by drugs can be enrolled, and patients with hyperthyroidism cannot be enrolled; 13) Patients sign a formal informed consent form to indicate that they understand that this study is in accordance with the hospital's policy and ethical requirements.
Exclusion criteria
Exclusion criteria: 1) Benign tumors of the head and neck; 2) Patients with any distant metastases; 3) Patients with any other malignancy in the past or present, except for non-melanomalous carcinoma of the skin or carcinoma in situ of the cervix; 4) Any other disease or condition that is contraindicated to immunotherapy or chemoradiotherapy (such as active infection, within 6 months after myocardial infarction, heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy after transplantation), pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objecitve Response Rate;1-year PFS; | — |
Countries
China
Contacts
Public ContactYuhong Lan
Hui Zhou Municipal Central Hospital
Outcome results
None listed