nasopharyngeal carcinoma
Conditions
Interventions
Case series:apatinib+capecitabine
Sponsors
Department of medical oncology,Sun Yet-Sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Recurrence and/or metastasis nasopharyngeal carcinoma that has been histologically confirmed as (1) Recurrence after radiotherapy; (2) Metastasis; 2. Patients who have failed at least first-line platinum-based chemotherapy; 3. Male or female patients aged 18-70 years; 4. ECOG PS: 0-2 point; 5. The Expected lifetime is over 3 months; 6. Patients not receiving chemotherapy or radiotherapy 4 weeks before the inclusion; 7. At least one lesion can be measured according to the RECIST standard (B-ultrasound, MRI or CT scan greater than 10 mm can be measured without radiotherapy); 8. The main organs function well: (1) blood routine examination: HGB > 80 g/L(no blood transfusion for fourteen days.); ANC> 1.5 x 10^9/L; PLT > 80x10^9/L; (2) Biochemical examination: TBIL 50 ml/min (Cockcroft-Gault formula); 9. Women of child-bearing age must have a pregnancy test (serum or urine) within 7 days prior to admission, and the results must be negative, and are willing to use a reliable method of contraception during the trial; 10. Signed the Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1) People who are known to be allergic to any of the studied drugs; 2) Pregnant or lactating women; 3) Have participated in other drug clinical trials within 4 weeks prior to screening; 4) Patients who have received >=two radiotherapy in the past; 5) Patients who have received previous treatment with VEGFR-targeted small molecule tyrosine kinase inhibitors (such as famitinib, sorafenib, sunitinib, rigofini, amlotinib, furquintini, etc.); 6) MRI showing tumor invasion of important blood vessels (such as the circumferential internal carotid artery/vein); Or the case that the patient's tumor is highly likely to affect important blood vessels and cause fatal massive hemorrhage during the treatment; 7) Have a history of severe bleeding, and any bleeding events with severe grading up to more than two degrees in CTCAE4.0 within 4 weeks prior to screening; 8) Patients with hypertension who cannot obtain good control through single hypotensive therapy (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg);Clinical significance (such as active) of cardiovascular disease - such as cerebrovascular accident (6 months before the randomization or less), myocardial infarction (6 months before the randomization or less), unstable angina, New York heart association (NYHA) classification of grade II or above of congestive heart failure, or severe arrhythmia drugs control or the test should not be used to treat potentially influence; 9) Patients with active ulcers, perforations and intestinal obstruction; 10) Patients with a history of gastrointestinal perforation within 28 days prior to screening; 11) A variety of factors (such as inability to swallow, postgastrectomy, chronic diarrhea, and intestinal obstruction) that affect the oral and absorption of drugs; 12) Patients with abnormal coagulation function and bleeding tendency (14 days prior to the signing of informed consent: INR is within the normal range without anticoagulants); Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues, who's International standardization in prothrombin time ratio (INR) under the premise of 1.5 or less, allowing purpose to prevent the use of low-dose warfarin (1 mg orally, once per day) or low-dose aspirin (amount does not exceed 100 mg daily); 13) 6 months prior to screening, suffering from artery or vein thrombosis events, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (line by chemotherapy venipuncture vein thrombosis by researchers have judgment recovered except) and pulmonary embolism, etc.; 14) Renal insufficiency: routine proteinuria > 2+ and 24-hour urinary protein quantification > 1.0 g; 15) Those who underwent major surgery within 28 days; 16) Patients who received strong CYP3A4 inhibitor treatment within one week prior to enrollment or received strong CYP3A4 inducer treatment within two weeks prior to study participation; 17) A wound that has not healed for a long time or a fracture that has not healed properly; 18) Symptomatic brain metastases (confirmed or suspected); 19) There are severe or uncontrolled infections; 20) Persons who have a history of psychotropic substance abuse and cannot be cured or have a history of mental disorders; 21) Have a history of immunodeficiency disorders, including HIV positive tests, other acquired, congenital immunodeficiency disorders, or a history of organ transplantation; 22) Patients with
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective tumor remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The safety and tolerance of the treatment;progression free survival;overall survival;DCR;Duration of response; | — |
Countries
China
Contacts
Public ContactSteven Cai
Department of medical oncology, Sun Yet-Sen University Cancer Center
Outcome results
None listed