Nasopharyngeal carcinoma
Conditions
Interventions
Experimental group:Erlotinib combined with Teggio
Sponsors
Nanxishan Hospital, Guangxi Zhuang Autonomous Region
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The histopathological diagnosis of non keratinization or undifferentiated carcinoma (WHO classification II type) in patients with advanced nasopharyngeal carcinoma has at least one measurable lesions. 2. Ages 18-70 years. 3. No hematologic diseases, WBC >= 3.5 x 10^9/L, PLT >= 100 x 10^9/L, HGB >= 80.0g/L before enrollment. 4. Liver function (ALT and AST = 60 ml/min; 5. Score 0-2 on EOCG. 6. Estimated survival time BBB 0 6 months. 7. Informed consent has been signed. 8. Expected survival >=12 weeks. 9. The main organs function normally, that is, they meet the following criteria: (1) blood routine examination :(no blood transfusion, no g-csf, no drug correction within 14 days before screening) HB >= 90 g/L or higher; The ANC >= 1.5 x 10^9 / L; PLT >= 80 x 10^9 / L; (2) biochemical examination :(no ALB was injected within 14 days) Propagated 29 g/L or higher; ALT and AST < 5xULN TBIL <= 1.5 x ULN Creatinine <= 1.5 x ULN (only one of the two criteria for albumin and bilirubin in child-pugh rating can have a score of 2.) 10. Women of child-bearing age must undergo a pregnancy test (serum or urine) within 7 days of enrollment, with a negative result, and be willing to use an appropriate method of contraception during the trial and 8 weeks after the last administration of the test drug. For males, surgical sterilization or consent to the use of an appropriate method of contraception during the trial and at 8 weeks after the last trial drug administration; 11. The subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Severe impairment of heart, liver and kidney; 2. A history of other malignancies. 3. A freak. 4. Positive urine protein; A long-term unhealed wound or fracture. 5. Prior to treatment, MRI showed that the tumor may have invaded important blood vessels (e.g., wrapping around the internal carotid artery/vein); Or a patient whose tumor, the researchers determined, had a high risk of invading important blood vessels and causing fatal bleeding during treatment. 6. Patients with hypertension who cannot get good control after single antihypertensive drug treatment (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); Patients with history of unstable angina pectoris; Patients with newly diagnosed angina pectoris within 3 months before screening or patients with myocardial infarction within 6 months before screening; Arrhythmias (including QTcF: >= 450ms in males and >= 470ms in females) require long-term use of antiarrhythmic drugs and grade II or greater cardiac dysfunction as classified by the New York heart association. Hyperarteriovenous/venous thrombotic events occurred in the previous year, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis (except for venous thrombosis caused by venous catheterization after chemotherapy) and pulmonary embolism. 7. With a history of severe bleeding, any bleeding event with a severe grade of 3 or above in CTCAE4.0 occurred within 4 weeks prior to screening. 8. Patients with abnormal coagulation function and bleeding tendency (14 days before the informed consent is signed, INR must be within the normal range without the use of anticoagulant); Patients treated with an anticoagulant or vitamin K antagonist such as warfarin, heparin, or its analogues; The use of a small dose of warfarin (1 mg per day) or a small dose of aspirin (100mg per day) for preventive purposes is permitted provided that the international standardized ratio of prothrombin time (INR) is .5% of the bone marrow region) in the 4 weeks prior to participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DCR;Adverse reactions; | — |
Countries
China
Contacts
Public ContactWu Dongmei
Nanxishan Hospital, Guangxi Zhuang Autonomous Region
Outcome results
None listed