Head and neck squamous cell carcinoma
Conditions
Interventions
Sponsors
Tumor Hospital Affiliated to Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. 18-70 years old; ECOG score: 0-1; 2. Patients who are pathologically diagnosed of advanced head and neck squamous cell carcinoma, including oropharyngeal carcinoma, hypopharyngeal carcinoma and laryngeal carcinoma, with measurable lesions (meeting RECIST 1.1 criteria); Resectable or potentially resectable after multidisciplinary discussion; 3. The expected survival time exceeds 6 months; 4. ECOG PS: 0~2 points; 5. Blood routine: WBC count >= 3.0x10^9/L, absolute value of neutrophils >= 1.5x10^9/L, platelet count >= 100x10^9/L, hemoglobin >= 90g/L; 6. Liver function: total bilirubin = 1.5 x ULN or creatinine clearance rate >= 50mL/min, and urine protein < 2+ (when baseline urine protein 2+, urine protein quantification should be performed for 24h, and only <= 1g can be included); 8. Within 7 days before the study and treatment, the international standardized rate (INR) was <= 1.5, with partial prothrombin protime (PTT or aPTT) <= 1.5x; 9. Non-lactation subjects and subjects of child-bearing age should take effective contraceptive measures; 10. Subjects voluntarily join the study and signed the informed consent, with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. The tumor has obviously invaded important blood vessels; 2. Abnormal coagulation; 3. Patients with severe cardiopulmonary dysfunction could not tolerate surgery; 4. Patients with hypertension and unable to obtain good control after antihypertensive drug treatment (systolic blood pressure >150 mmHg, diastolic blood pressure >100 mmHg); 5. Have the following cardiovascular diseases: grade II or above myocardial ischemia or myocardial infarction, dysrhythmia with poor control, grade III~IV cardiac function, or cardiac ejection fraction 1.5 or PT > ULN+4 seconds or APTT > 1.5 ULN), bleeding tendency or receiving thrombolytic or anticoagulant therapy; 7. There are significant factors affecting the absorption of oral medicine; 8. Patients with positive urinary protein; 9. Accompanied by a serious uncontrolled infection or medical disease; 10. Participated in clinical trials of other drugs 4 weeks before enrollment; 11. Those with a known history of psychotropic substance abuse, alcohol abuse or drug abuse that cannot be cured or have a mental disorder; 12. Failure to follow up regularly due to psychological, social, family and geographical reasons; 13. The researchers did not think the participants were suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Tumor complete resection rate;Pathological complete response rate;Drug safety;Quality of life score; | — |
Countries
China
Contacts
Public ContactXu Jian
Tumor Hospital Affiliated to Guangxi Medical University
Outcome results
None listed