cancer
Conditions
Interventions
case series:Apatinib maintenance therapy
Sponsors
First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years old, male or female; 2. Pathologically diagnosed advanced head and neck squamous cell carcinoma with measurable lesions (spiral CT scan >=10mm, meeting RECIST 1.1 criteria); 3. Patients with head and neck squamous cell carcinoma who have been treated with conventional chemoradiotherapy and identified as relapsed or metastatic; 4. ECOG PS: 0-2 points; 5. Subjects Blood routine and biochemical indicators meet the following criteria: Hemoglobin >=80g/L, The absolute neutrophil count (ANC) is >1.5x10^9/L, platelets >=80x10^9/L, ALT, AST=30g/L; 6. The estimated survival period is >=3 months; 7. Sign the informed consent form (ICF) prior to the study; 8. Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days prior to enrollment and the results are negative, and are willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the test drug. For men, surgery should be sterilized, or consent should be used during the trial and 8 weeks after the last administration of the test drug.
Exclusion criteria
Exclusion criteria: 1. Allergies to apatinib mesylate and/or its excipients have been confirmed; 2. Patients with hypertension and antihypertensive medication can not be reduced to normal range (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg), with grade I or higher coronary heart disease, grade I arrhythmia (including QTc interval prolongation) Male >450 ms, female >470 ms) and grade I cardiac insufficiency; urine protein positive patients; 3. Have multiple factors affecting oral medications (such as inability to swallow, nausea, vomiting, chronic diarrhea, and intestinal obstruction); 4. Patients with a clear tendency to localized tumor bleeding; 5. abnormal blood coagulation (INR>1.5, APTT>1.5 ULN), with bleeding tendency; 6. Accompanied by central nervous system metastasis; 7. Pregnant or lactating women; 8. Have other malignant tumors within 5 years; 9. Persons with a history of psychotropic substance abuse who are unable to quit or have a mental disorder; 10. Participated in other drug clinical trials within four weeks; 11. Have received VEGFR inhibitors such as sorafenib and sunitinib; 12. According to the investigator's judgment, there are serious concomitant diseases that compromise the safety of the patient or affect the patient's completion of the study; 13. Patients with previous and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-associated pneumonia, severe impaired lung function, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;DCR;ORR; | — |
Countries
China
Contacts
Public ContactXin Jiang
First Hospital of Jilin University
Outcome results
None listed