Squamous cell carcinoma of the head and neck
Conditions
Interventions
Experimental Group:Adebrelimab combined with apatinib mesylate
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Have a full understanding of this study and voluntarily sign the informed consent form; 2. Age 18-75 years old; 3. Localized advanced head and neck squamous cell carcinoma confirmed by pathological histology or cytology and can be operated upon by the surgeon (oral, oropharyngeal, hypopharyngeal cancer, laryngeal cancer); 4. ECOG score of 0-1 points; 5. Estimated survival >=6 months; 6. Have at least one measurable lesion (according to RECIST1.1); 7. The function of major organs is normal, and the test results at screening must meet the following requirements: (1) The criteria for routine blood examination must be met (no blood transfusion and blood products within 14 days, no correction with G-CSF and other hematopoietic stimulating factors): A. Hemoglobin (Hb) > = 90 g/L; B. Neutrophil count (ANC) > = 1.5×10^9/L; C. Platelet count (PLT) >= 80 ×10^9/L; (2) Biochemical tests must meet the following criteria: A. Total bilirubin (TBIL) 60ml/min (Cockcroft-Gault formula); D. Urine routine test results showed urine protein (UPRO) < 2+ or 24-hour urine protein quantification <1g; (3) Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) =low limit of normal (50%); (4) International normalized ratio (INR) <=1.5×ULN and activated partial thromboplastin time <=1.5×ULN; 8. Contraception: Females of childbearing age should agree to use effective contraceptive measures during the study period and within 6 months after the end of the study; Negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient; Male should agree that contraception must be used for the duration of the study and for 6 months after the end of the study period;
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to therapeutic drugs; 2. Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; Congestive heart failure with a New York Heart Association (NYHA) grade of>= 2; Arrhythmia (including QTc interval >= 450 ms in men and =>=470 ms in women); Left ventricular ejection fraction (LVEF) 140mmHg or diastolic blood pressure >90mmHg; 4. Urine routine test indicates urine protein >=++, and it is confirmed that the 24-hour urine protein quantification is > 1.0g; 5. Surgical operations (excluding biopsy) or surgical incisions that have not fully healed within 28 days prior to inclusion in this study; 6. Patients whose imaging shows that the tumor has invaded the area around important blood vessels or whose researchers have determined that the tumor is highly likely to invade important blood vessels and cause fatal massive hemorrhage during the subsequent study period; 7. Those with a history of abuse of psychotropic drugs and unable to quit or with mental disorders; 8. Active or uncontrolled severe infection; 9. The patient has any active autoimmune diseases or a history of autoimmune diseases (such as the following, but not limited to: autoimmune hepatitis, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; The patient has vitiligo. Asthma that has been completely relieved during childhood and does not require any intervention in adulthood can be included. Asthma patients who require medical intervention with bronchodilators cannot be included. 10. A known history of significant liver disease, including but not limited to known hepatitis B virus (HBV) infection and positive HBV DNA (>=500IU/ml or 1000copies/ml); Known hepatitis C virus infection (HCV) with positive HCV RNA (HCV-RNA higher than the detection limit of the analytical method), or liver cirrhosis, etc. 11. Patients who are currently using immunosuppressants or systemic hormone therapy to achieve immunosuppressive effects (dose >10mg/ day prednisone or other therapeutic hormones) and are still using them within 2 weeks prior to enrollment; 12. Patients with pulmonary fibrosis, interstitial pneumonia and severe lung function impairment; 13. Those who receive attenuated live vaccines within 30 days of their first administration or are expected to receive them during the study period; 14. Pregnant women (with a positive pregnancy test before medication) or those who are breastfeeding; 15. Currently participating in interventional clinical research treatment, or having received treatment with other investigational drugs or research devices within 4 weeks prior to the first administration; Before the first administration, there was no full recovery from the toxicity and/or complications caused by any intervention measures (i.e., <= grade 1 or reaching the baseline, excluding fatigue or alopecia); 16. The subjects have already received or plan to receive solid organ or blood system transplants (except corneal 17.transplants) during the study period; According to the researcher's judgment, patients who are considered unsuitable for enrollment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathological Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological Complete Response;Overall survival;Objective response Rate; | — |
Countries
china
Contacts
Public ContactXin guang Han
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed