Head and neck squamous cell carcinoma
Conditions
Interventions
experimental group:Teriprizumab injection+Nedaplatin+Docetaxel
Sponsors
Guangxi Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-70 years old; ECOG score 0-1 points; 2. Advanced head and neck squamous cell carcinoma diagnosed pathologically, including neck tumors, ENT tumors, and oral and maxillofacial tumors, with measurable lesions (meets RECIST 1.1 standard); After multidisciplinary discussion, it is resectable or potentially resectable; 3. The expected survival time exceeds 6 months; 4. ECOG PS: 0~2 points; 5. Routine blood test: white blood cell count >= 3.0 x 10^9/L, absolute neutrophil count >= 1.5 x 10^9/L, platelet count>= 100 x 10^9/L, hemoglobin >= 90g/L; 6. Liver function: total bilirubin = 50mL/min, and urine protein < 2+ (when the baseline urine protein is 2+, 24h urine protein quantification should be performed, and it can be selected only when it is <= 1g); 8. Within 7 days before the study treatment, the international normalized ratio (INR) <= 1.5, and the partial prothrombin time (PTT or aPTT)<= 1.5x; 9. Non-lactating subjects and subjects of childbearing age should take effective contraceptive measures; 10. The subjects voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Abnormal blood clotting exists; 2. Those who are allergic to PD-1 monoclonal antibody; 3. A history of other malignant tumors within the past 5 years or at the same time, except for cured skin basal cell carcinoma, cervical carcinoma in situ, and thyroid papillary carcinoma; 4. Patients with any history of active autoimmune disease or autoimmune disease; 5. Complicated diseases that require the use of immunosuppressive drugs; concurrent diseases that require the use of immunosuppressant amounts of systemically or locally absorbable corticosteroids. It is forbidden to use prednisone greater than 10 mg/day or the same dose in the 2 weeks before the use of the study drug; 6. History of immunodeficiency or human immunodeficiency virus (HIV) infection 7. Combined with severe cardiopulmonary dysfunction, cannot tolerate surgery; 8. Have the following cardiovascular diseases: Myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia, cardiac function grade III to IV, or cardiac ejection fraction 1.5 or PT > ULN+4 seconds or APTT > 1.5 ULN), have bleeding tendency or are receiving thrombolytic or anticoagulant therapy; 10. Accompanied by serious uncontrollable infections or medical diseases; 11. Participated in other drug clinical trials 4 weeks before enrollment; 12. People who are known to have a history of psychotropic drug abuse, alcohol or drug abuse and cannot be quitted or have mental disorders; 13. Unable to cooperate with regular follow-up due to psychological, social, family and geographic reasons; 14. The investigator believes that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathologic complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Main pathological response;Local-Regional failure free survial;Recurrence-free survival;R0 resection rate;Living quality;Drug safety; | — |
Countries
China
Contacts
Public ContactXu Jian
Guangxi Medical University Cancer Hospital
Outcome results
None listed