nasopharyngeal carcinoma (NPC)
Conditions
Interventions
Case series:Icotinib
Sponsors
The First affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically proven NPC diagnosis, Patients who failed the prior standard treatment or were intolerant of standard treatment; 2. Patients who have received at least 1 previous lines of platinum containing therapy prior to randomisation; 3. Aged between 18-75 years; 4. Patients with at least one measurable lesion meeting RECIST 1.1; 5. ECOG Performance Status of 0, 1, 2; 6. Life expectancy of at least 12 weeks; 7. Adequate organ function, meeting the following criteria:Bone marrow: absolute neutrophil count (ANC) more than 1.5*10^9/L, Platelet count more than 75*10^9/L, Hemoglobin more than 9 g/dL; Hepatic: bilirubin less than 2 times the upper limit of normal, ALT and AST less than 2.5*upper limit of normal (less than 5*upper limit of normal are acceptable if the liver has tumor involvement); Renal: Serum Creatinine less than 1.5 times the upper limit of normal; 8. Female: Women of childbearing potential must have a urine pregnancy test taken and proven negative within 7. days prior to the treatment and must not be lactating; Male: Must be surgically sterile or compliant with a contraceptive regimen during and for 12 weeks after the treatment; 9. Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
Exclusion criteria: 1. Previously received epidermal growth factor receptor (EGFR)-targeted therapy; 2. Concurrent treatment with sodium phenytoin, carbamazepine, rifampin, barbital or Sant Jone grass; 3. Received unapproved drug and other investigational drug within 4 weeks prior to randomization ; 4. Received other anti-tumor therapy meanwhile; 5. Patients with known brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events; 6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; 7. Pregnant or breast-feeding females; 8. Inability to comply with protocol or study procedures in the opinion of the investigator (management or any other reasons).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DCR;PFS;OS; | — |
Countries
China
Contacts
Public ContactHu Xiaohua
Outcome results
None listed