Stage III-IVA resectable squamous cell carcinoma of the head and neck
Conditions
Interventions
Sponsors
Department of Otolaryngology, Mianyang Central Hospital, Sichuan Province
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years; ECOG score 0-1 points; 2. Advanced head and neck squamous cell carcinoma diagnosed pathologically, including oropharyngeal carcinoma, hypopharyngeal carcinoma and laryngeal carcinoma, with measurable lesions (meets RECIST 1.1 standard); it is resectable or potentially resectable after multidisciplinary discussion; 3. The expected survival time exceeds 6 months; 4. ECOG PS: 0-2 points; 5. Routine blood test: white blood cell count >=3.0x10^9/L, absolute neutrophil count >=1.5x10^9/L, platelet count >=100x10^9/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 <=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. Unable to cooperate with regular follow-up due to psychological, social, family and geographic reasons; 2. The investigator believes that it is not suitable for inclusion; 3. The tumor has obviously invaded important blood vessels; 4. Abnormal blood clotting exists; 5. Combined with severe cardiopulmonary dysfunction and cannot tolerate surgery; 6. Patients who have high blood pressure and cannot be well controlled by antihypertensive drugs (systolic blood pressure> 150 mmHg, diastolic blood pressure> 100 mmHg); 7. 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 thrombolysis or anticoagulation therapy; 9. There are factors that significantly affect the absorption of oral drugs; 10. Patients with positive urine protein; 11. Accompanied by serious uncontrollable infections or medical diseases; 12. Participated in other drug clinical trials 4 weeks before enrollment; 13. Patients who are known to have a history of psychotropic drug abuse, alcohol or drug abuse and cannot be quit, or have mental disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;Progression-free survival;Tumor complete resection rate;Overall survival; | — |
Countries
China
Contacts
Public ContactJiang Zhenhua
Department of Otolaryngology, Mianyang Central Hospital, Sichuan Province
Outcome results
None listed