head and neck carcinoma
Conditions
Interventions
experimental group:Targeted therapy with anlotinib
Sponsors
The First Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Male or female, aged 18 to 75 years; 2. PS score = 80 mL/min; 9. Adequate blood function: absolute neutrophil count (ANC) >= 2 * 10^9/L, platelet count >= 100 * 10^9/L and hemoglobin >= 9g/dL; 10. No serious heart, lung and other important organ dysfunction; 11. Women of childbearing age must have taken reliable contraceptive measures; pregnancy tests (serum or urine) are negative within 7 days before enrollment, and must be non-lactating patients; and are willing to adopt appropriate during the test and within 6 months after the last treatment Methods of contraception. For men, it is necessary to agree to use appropriate methods of contraception or surgical sterilization during the trial and 8 weeks after the last dose; 12. The subjects voluntarily joined the study and signed an informed consent form with good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Can undergo radical surgery or cannot tolerate anti-tumor treatment; 2. Women who are pregnant or breastfeeding, have fertility but are unwilling or unable to take effective contraceptive measures; 3. People with high blood pressure who cannot be well controlled by antihypertensive drugs (systolic blood pressure> 150 mmHg, diastolic blood pressure> 100 mmHg); 4. Patients with clinically significant cardiovascular disease within 6 months before enrollment, including uncontrolled hypertension, myocardial infarction, or unstable angina; New York Heart Association (NYHA) congestive heart failure of grade II or higher, severe Of arrhythmia requiring treatment (including QT interval >= 440 ms), or cardiac ejection fraction 1.5 or prothrombin time (PT) > ULN+4 seconds or APTT > 1.5 ULN), have bleeding tendency or are undergoing thrombolysis or anticoagulation treatment; 6. There was obvious hemoptysis blood 2 months before enrollment, or the daily hemoptysis amount was 2.5ml or more; 7. Significant clinically significant bleeding symptoms or clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline occult blood ++ and above, or suffering from vasculitis within 3 months before enrollment; Known hereditary or acquired bleeding and thrombotic tendency; 8. Arterial/venous thromboembolic events within 12 months before enrollment; 9. Have undergone major surgery within 4 weeks of enrollment or accompanied by severe, non-healing wounds, ulcers or fractures; 10. There are obvious factors that affect the absorption of oral drugs; 11. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred 6 months before enrollment; 12. Urinary routines suggest that urine protein is >= ++, and that the amount of urine protein in 24 hours is >= 1.0g; 13. Serous cavity fluid accumulation with clinical symptoms and requiring symptomatic treatment; 14. Active infections require antimicrobial treatment; 15. Have a history of central nervous system diseases, including primary brain tumors, seizures without standard medication, any brain metastases or have cerebrovascular accidents (CVA, stroke), transient ischemic attack (TIA), or 6 A history of subarachnoid hemorrhage within the month; 16. Participated in clinical trials of other drugs 4 weeks before enrollment; 17. Other malignant tumors in the past or at the same time (except for malignant tumors that have been cured and survived for more than 5 years without cancer, such as basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroid carcinoma, etc.); 18. Those who have received VEGFR inhibitors, such as pazopanib, sunitinib, sorafenib, rigofenib, etc.; 19. Those who are known to have a history of psychotropic substance abuse, alcoholism or drug use and are unable to quit or have mental disorders; 20. The investigator judges other conditions that may affect the progress of the clinical study and the judgment of the research results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Object remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Quality of life score; | — |
Countries
China
Contacts
Public ContactYong Chen
The First Affiliated Hospital of Sun Yat-Sen University
Outcome results
None listed