Recurrent and/or metastatic head and neck squamous cell carcinoma
Conditions
Interventions
Case series:Anlotinib hydrochloride capsule: 12mg po qd, taken orally before breakfast. Continuous use for 2 weeks, drug withdrawal for 1 week, 3 weeks for 1 cycle.
Sponsors
The First Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–70 years old, male or female; 2. Pathologically diagnosed advanced head and neck squamous cell carcinoma, including oropharyngeal cancer, hypopharyngeal cancer and laryngeal cancer, with measurable lesions (meeting RECIST 1.1 criteria); 3. Late, recurrent or metastatic malignant tumors of the head and neck that are inoperable and radiotherapy; 4. Disease progression after second-line and above chemotherapy or intolerance or refusing chemotherapy; 5. ECOG PS: 0-2 points; 6. The expected survival period is =3 months 7. Baseline blood and biochemical indicators meet the following criteria: Hemoglobin =90g/L; Absolute neutrophil count =1.5×10^9/L; Platelets =100×10^9/L; Absolute white blood cell count =3×10^9/L; ALT, AST =5×upper limit of normal (ULN); Serum total bilirubin =1.5×ULN; Serum creatinine <1.5×ULN; Serum albumin =2.8g/dL; 9. patients of childbearing age must be willing to use appropriate methods of contraception; 10. Subjects voluntarily joined the study, signed informed consent, and were well-adhered to follow-up.
Exclusion criteria
Exclusion criteria: 1. Pregnancy or breast feeding; 2. Patients with hypertension and antihypertensive medication can not be reduced to normal range (systolic blood pressure >150 mmHg, diastolic blood pressure >100 mmHg); 3. Patients with grade II or higher myocardial infarction, arrhythmia, grade III~IV cardiac function or cardiac ejection fraction 1.5 or PT>ULN+4s or APTT>1.5 ULN), with bleeding tendency, or receiving thrombolytic or anticoagulant therapy; 5. Following conditions within 4 weeks before enrollment: underwent major surgery, had a history of serious trauma; 6. Have multiple factors affecting oral medications; 7. Urine protein positive patients; 8. Accompanied by serious uncontrollable infection or medical diseases; 9. A person who has been confirmed to be allergic to Anlotinib and/or its excipients; 10. Patients with central nervous system metastases; 11. Patients who have participated in other drug clinical trials within 4 weeks; 12. Patients with a history of psychotropic substance abuse who are unable to quit or have a mental disorder; 13. Patients unable to be followed up regularly; 14. With severe heart, lung, liver, kidney and other important organ dysfunction; 15. The investigator believes that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Remission Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Overall Survival;Disease Control Rate;Quality of Life; | — |
Countries
China
Contacts
Public ContactLei Wenbin
The First Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed