EGFR wild-type non-squamous NSCLC with multiple brain metastases
Conditions
Interventions
case series:Apatinib combined with radiotherapy
Sponsors
Yunnan Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Obtain informed consent forms from the patients; 2. Eligible patients are pathologically diagnosed with advanced non-squamous, non-small cell lung cancer, and multiple brain metastasis (> 4 visible lesions); 3. Patients are EGFR mutation negative(wild-type EGFR) confirmed by EGFR mutation detection(ARMS); 4. ECOG PS score: 0-2 points; According to RECIST and revised RECIST standards, At least one lesion can be detected by MRI scan: (1) A single lesion>5cm; (2) 2 or 3 lesions, at least one lesion>3cm; (3) 4 or over 4 lesions, no limitation required for the maximum diameter; 5. Expected survival time=12 weeks; 6. Subjects who participated in this study must take appropriate contraceptive measures over the period of the trial and within the 4 weeks after the trial; 7. Within 7 days of grouping, Subjects who participated in this study must be able to maintain sufficient liver and kidney function, unprocessed indicators: 8. HGB=9.0g/dl, neutrophil>=1500/mm3, PLT=50×10^9/L, serum ALB=28g/L, TBIL<2mg/dl, ALT & AST<5 times of normal upper limit, Bun & Cr<1.5 times normal upper limit, INR or PT prolong<4s; 9. Recurrence and progression of disease due to loss of drug sensitivity of first-line chemotherapy.
Exclusion criteria
Exclusion criteria: 1. Portal vein and any vascular invasion; 2. Tumor load>50%; 3. Patients with hypertension and the blood pressure cannot be reduced down to normal range by antihypertensive drugs (Systolic pressure > 140 mmHg, diastolic pressure > 90 mmHg); 4. Patients with level II or above myocardial ischemia or myocardial infarction, poor control arrhythmia (Including QTC interval in male=450ms, QTC interval in female=470ms); 5. Combined HIV-infected patients; 6. Patients with kidney failure or renal function disorder, blood or peritoneal dialysis is required; 7. Multiple factors that could influence oral drug administration (eg. Inability to swallow, Chronic diarrhea and intestinal obstruction, Under several particular circumstances, drug administration and absorption could be significantly influenced); 8. In past 6 months, patient has a history of gastrointestinal bleeding or clear tendency of gastrointestinal bleeding, eg. Patients with esophageal varices with bleeding risk, local active ulcer lesions and defecate occult blood=(++) are prohibited into group, gastroscopy is necessarily demanded for patients with defecate occult blood=(+); 9. Serious active clinical infection (>2 level, NCI-CTCAE version 4.0), HBV and HCV infectious are excluded; 10. Urinary protein detected by urine routine test= ++ or 24-hour urinary protein quantity is proved >1.0g; 11. Pregnant or lactating women, patients with fertility are unwilling or unable to take effective contraceptive measures; 12. Patients accepted major surgeries within the first 4 weeks before this clinical trial (eg.ntrathoracic, intraperitoneal or pelvic cavity), or patients have not yet completely recovered from this kind of surgeries).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intracranial Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Duration of response;Objective response rate;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactWenhui Li
Yunnan Cancer Hospital
Outcome results
None listed