EGFR mutation
Conditions
Interventions
Case series:apatinib
Sponsors
Tangshan People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years old EGFR-mutant patients with EGFR-TKI drug resistance; 2. At least one measurable lung, extrapulmonary metastatic lesion (Tumor lesion CT scan long diameter =10 mm, meeting RECIST 1.1 criteria); 3. Recurrence or failure after first-line treatment; 4. Life expectancy greater than or equal to 3 months; 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 6. Major organ function has to meet the following criteria: (1) Baseline blood indicators meet the following criteria (without blood transfusion and blood products within 14 days, and not corrected by G-CSF and other hematopoietic stimulating factors): HB=90g/L; ANC=1.5×10^9/L; PLT=100×10^9/L; (2) Baseline biochemical indicators meet the following criteria: TBIL<1.5×ULN; ALT and AST<2.5×ULN, but<5×ULN if the transferanse elevation is due to liver metastases; Serum creatinine=1.25×ULN; Endogenous creatinine clearance rate 45 ml/min; 7. Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 7 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. Men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks; 8. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Has been confirmed to be allergic to apatinib; 2. Have high blood pressure and antihypertensive drug treatment can not reduced to the normal range (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); With class II and above myocardial ischemia or myocardial infarction (including QTc lengthened men > 450 ms and women > 470 ms ), and class III-IV cardiac insufficiency; 3. A variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc); 4. Patients who had history of hemoptysis within 2 months; 5. Patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (++).Has melena and hematemesis in two months; 6. Coagulant function abnormality (INR > 1.5, APPT>1.5ULN), with bleeding tendency; 7. Patients with symptomatic central nervous system metastasis; 8. Patients with pregnant or planning a pregnancy; 9. History of psychiatric drugs abuse and can't quit or patients with mental disorders; 10. Less than 4 weeks from the last clinical trial; 11. The researchers think inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival ; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3. Overall survival; Objective response rate;Disease control rate;Safety; | — |
Countries
China
Contacts
Public ContactDong Guilan
Tangshan People's Hospital
Outcome results
None listed