cancer
Conditions
Interventions
Case Series:apatinib in combination with chemotherapy
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18~75 years, male or female. 2. Histologically(including histology or cytology) confirmed recurrent or metastatic SCCHN (oral cavity, pharynx, larynx) with at least one measurable lesion (according to RECIST 1.1 criteria). 3. Platinum treatment failure of head and neck squamous cell carcinoma: Tumor progression or recurrence during platinum therapy; Tumor progression or recurrence within 6 months of last dose of platinum therapy. 4. ECOG PS: 0-2 points. 5. Estimated survival time = 3 months. 6. The main organs function normally and meet the following requirements: Blood routine examination, need to meet (no blood transfusion within 14 days) a) HB=85g/L; b) ANC =1.5×10^9/L; c) PLT =80×10^9/L. Biochemical examinations must meet the following criteria a) BIL <1.5ULNIf there is liver metastasesBIL<3ULN; b) ALT and AST<2.5×ULNIf there is liver metastasesALT and AST<5×ULN; c) Serum Cr=1×ULNEndogenous creatinine clearance=50ml/min (Cockcroft-Gault formula). 7. Women of childbearing age must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment meanwhile volunteer to use appropriate methods for contraception during the observation period and within 8 weeks after the last administration of apatinib mesylate tablets; Men should be surgical sterilized, or agree to use appropriate methods of contraception within 8 weeks after the observation and the last administration of apatinib mesylate tablets; 8. Patients volunteered to join the study and signed informed consent (ICF); 9. Those who are expected to have good compliance can follow up the efficacy and adverse reactions according to the program requirements.
Exclusion criteria
Exclusion criteria: 1.Patients with hypertension unable to fall to normal range with antihypertensive medication (systolic blood pressure >140 mmHg / diastolic blood pressure > 90 mmHg), with coronary heart disease (= grade II), arrhythmia (including QTc prolongation in men >450 ms, female >470 ms and cardiac insufficiency). 2.Patients who have a variety of factors affecting oral drug absorption (such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction). 3.Patients with a risk of gastrointestinal bleeding may not be enrolled, including the following: (1) active digestive ulcer lesions and fecal occult blood (++); (2) those with a history of melena and hematemesis within 3 months. 4.Urine protein positive patients (urinary protein detection 2+ or above, or 24-hour urine protein quantitation > 1.0g). 5.Abnormal coagulation(INR>1.5×ULNAPTT>1.5×ULN)Have a tendency to hemorrhage. 6.Dynamic or venous thrombosis events occurring within the first 12 months of screening, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism. 7. Uncontrollable infection during screening. 8. Patients with a history of psychotropic substance abuse who are unable to quit or have a mental disorder. 9. According to the investigator's judgment, there are other patients who are seriously at risk to the patient's safety or affect the patient's accompanying disease. 10. Pregnant or lactating woman. 11. Those who researchers believe that it is not suitable for inclusion. 12. Patients with only cancerous pleural and ascites, lymphatic metastasis, bone metastasis, cerebrospinal membrane and other unmeasurable lesions. 13.Pations who are severely allergic to any ingredient of apatinib. 14. Who have previous treatment with apatinib or other vascular endothelial inhibitors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;PFS;DCR;QoL; | — |
Countries
China
Contacts
Public ContactFujun Han
The First Hospital of Jilin University
Outcome results
None listed