Head and neck squamous cell carcinoma
Conditions
Interventions
stage ? :Nytuzumab was combined with ipilimumab
stage II:Nytuzumab was combined with ipilimumab
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years, including 18 and 80; 2. Confirmed by histopathology or cytology, MRI diagnosis was resectable stage II-III head and neck squamous cell carcinoma (including oral cancer, oropharyngeal cancer, laryngeal cancer and hypopharyngeal cancer); 3. ECOG PS score 0-2; 4. Immunohistochemical examination of histopathology showed positive expression of EGFR; 5. P16 and EBER were negative in histopathological immunohistochemistry; 6. Lymph nodes have signs of extracapsular invasion (MRI, CT or pathology); 7. According to RECIST version 1.1 evaluation criteria, there is at least one measurable lesion; 8. Expected survival time >= 6 months; 9. Hematological indexes are basically normal:Leukocyte count >= 4 x 10^9/L, Absolute neutrophil count >= 1.5 x 10^9/L, Platelet >= 100 x 10^9/L, Hemoglobin >= 90 g/L; 10. Renal function is basically normal:Serum creatinine 60 ml/min (using Cockcroft Gault formula): Female crcl = (140 age) x Weight (kg) x 0.85 / (72 x Scr mg/dl); Male crcl = (140 age) x Weight (kg) x 1.00/(72 x Scr mg/dl); 11. Liver function is basically normal:Total serum bilirubin <= 1.5 x ULN, Aspartate aminotransferase (AST) <= 2.5 x ULN, Alanine aminotransferase (ALT) <= 2.5 x ULN; 12. Female patients must have a negative urine pregnancy test before the start of the study (not applicable to patients with bilateral ovariectomy and/or hysterectomy or postmenopausal patients); 13. Sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. Received PD-1 inhibitor, EGFR monoclonal antibody, EGFR-TKI and anti angiogenesis drugs within 4 weeks before enrollment; 2. Participated in other interventional clinical trials within 30 days before screening; 3. People with a history of other malignant tumors (except for 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 disease, etc.); 5. Known to be infected with HIV or active viral hepatitis or tuberculosis; 6. Major surgery or planned surgery within 30 days before the first administration of the investigational drug; 7. Those who are allergic to the drugs or their components used in this protocol; 8. Pregnant (confirmed by blood or urine HCG test) or lactating women, or subjects of childbearing age are unwilling or unable to take effective contraceptive measures (applicable to both male and female subjects) until at least 6 months after the last trial treatment; 9. The researcher believes that it is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response;major pathological response;objective response rate;Organ function retention rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Perioperative complication rate;Event-free survival;Surgery delay rate;R0 resection rate;1-year disease-free survival;2-year disease-free survival;3-year disease-free survival; | — |
Countries
China
Contacts
Public ContactLiang Zheng
Tianjin Medical University General Hospital
Outcome results
None listed