Head and neck squamous cell carcinoma
Conditions
Interventions
Study arm:Nimotuzumab combined with chemotherapy (PF protocol)
Sponsors
Xijing Hospital of the Air Force Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. 18-80 years old, including 18 and 80 years old; 2. Resectable stage III to IVa head and neck squamous cell carcinoma (including oropharyngeal carcinoma, laryngeal carcinoma and hypopharyngeal carcinoma) was confirmed by histopathology or cytology by MRI imaging; 3. ECOG PS score 0-2; 4. Histopathological immunohistochemical test indicated positive EGFR expression; 5. Histopathological immunohistochemical tests were P16 negative and EBER negative; 6. Lymph nodes have signs of extraperitoneal invasion (MRI, CT or pathology); 7. At least one measurable lesion according to RECIST 1.1 evaluation criteria; 8. Expected survival time >=6 months; 9. Hematologic indexes were basically normal: white blood cell count >=4*10^9/L; Neutrophil absolute count >=1.5*10^9/L; Platelet >=100*10^9/L; Hemoglobin >=90 g/L; 10. Normal renal function: serum creatinine 60 mL/min(Cockcroft-Gault formula was used): (1) Female CrCl=(140-age)* body weight (kg)* 0.85 / (72*Scr mg/dL); (2) Male CrCl=(140-age)* body weight (kg)* 1.00 / (72*Scr mg/dl); 11. Normal liver function: serum total bilirubin <=1.5*ULN; Aspartate aminotransferase (AST) <=2.5*ULN; Alanine aminotransferase (ALT) <=2.5*ULN; 12. Female patients must have a negative urinary pregnancy test prior to study initiation (not available in patients with bilateral oophorectomy and/or hysterectomy or postmenopausal patients); 13. Signed written informed consent.
Exclusion criteria
Exclusion criteria: 1. Received PD-1 inhibitor, EGFR mab, EGFR-TKI and anti-angiogenic drugs within 4 weeks before enrollment; 2. Participating in other interventional clinical trials within 30 days prior to screening; 3. History of other malignant tumors (except cured basal cell carcinoma of the skin); 4. There are serious and poorly controlled concurrent diseases (such as heart failure, diabetes, hypertension, liver failure, renal failure, thyroid disease, mental illness, etc.); 5. Known to be infected with HIV or active viral hepatitis or tuberculosis; 6. Major surgical or planned surgery within 30 days of the first administration of the investigational drug; 7. Allergic to drugs or ingredients used in the program; 8. Women who are pregnant (as confirmed by blood or urine HCG testing) or who are lactating, or subjects of childbearing age are unwilling or unable to use effective contraceptive methods (for both male and female subjects) until at least 6 months after the last trial treatment; 9. The researcher considers it inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response rate of primary lesion;Organ retention rate;1 year overall survival rate;1 year disease-free survival rate;The quality of life;Safety; | — |
Countries
China
Contacts
Public ContactShi Li
Xijing Hospital of the Air Force Military Medical University
Outcome results
None listed