Stereotactic Radiosurgery Combination With Anlotinib for Limited Brain Metastases in NSCLC

Study Overview
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Brief Summary
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The purpose of this study is to determine whether stereotactic radiosurgery combination with Anlotinib could improve the efficacy and outcomes for non-small cell lung cancer with limited brain metastases.

Detailed Description
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This is a retrospective study. The purpose of this study is to determine whether stereotactic radiosurgery combination with Anlotinib could improve the efficacy and outcomes for non-small cell lung cancer with limited brain metastases. Patients in Anlotinib group took Anlotinib 1 week before the MRI-based simulation，12mg/d QD，day1 14, 21d/cycle. Patients in SBRT group took no anti-angiogenic drugs. All patients received SBRT for brain metastases.

Official Title
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Stereotactic Radiosurgery Combination With Anlotinib for Limited Brain Metastases in Non-small Cell Lung Cancer

Conditions
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Stereotactic Body Radiation Therapy

Intervention / Treatment
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* Drug: Anlotinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients pathologically diagnosed as non-small cell lung cancer, with brain metastases and measurable lesions; Patients aged between 18 -80 years; with expected survival time>3 months. Patients with no more than 5 brain metastases Patients with normal organ function within 7 days prior to treatment, the following criteria are met: blood routine examination criteria : i) hemoglobin (HB) ≥90g/L; ii) absolute neutrophil count (ANC) ≥1.5×10e9/L; iii) platelet (PLT) ≥80×10e9/L; b) biochemical tests meet the following criteria: i) total bilirubin (TBIL) ≤1.5 times of upper limit of normal (ULN); ii) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 ULN, if liver metastasis occurred, ALT and AST ≤5 ULN; iii) serum creatinine (Cr) ≤1.5 ULN or creatinine clearance (CCr) ≥60mL/min; Exclusion Criteria: Patients who had previously used antiangiogenic agents within 1 month; Patients with small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer); Patient with lung squamous cell carcinoma that involved pulmonary hilar, or non-small cell lung cancer with hemoptysis; Patients with cerebral infarction and cerebral hemorrhage; Patients without perilesional edema； Patients with more than grade 2 (NCI-CTCAE v4.0) acute toxicity reaction due to any previous treatment. Patients with factors that affect oral medication (such as cannot swallow, chronic diarrhea and intestinal obstruction, etc.); Patients with visceral dissemination or severe symptoms, which could cause death in short term; Patients with any other severe and/or uncontrolled disease; Patients who received a surgery, a biopsy or a significant traumatic injury within 1 month; Patients with any signs or medical history of bleeding, unhealed wounds, ulcers or fractures, regardless of the severity; Patients underwent artery or venous thrombotic events within 2 months, such as deep vein thrombosis and pulmonary embolism; Patients with a history of psychotropic medicine abuse and cannot quit or have mental disorders; Patients with disease which will severely endanger their security and could not complete this study, according to the judgement of researchers；

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anlotinib group<br>Patients in Anlotinib group took Anlotinib 1 week before the MRI-based simulation，12mg/d QD，day1 14, 21d/cycle. All patients received SBRT for brain metastases. | Drug: Anlotinib<br>* Anlotinib is a novel multi-target tyrosine Kinase inhibitor that inhibits VEGFR2/3, FGFR1-4, PDGFD α/β, c-Kit and Ret. Stereotactic Radiosurgery Stereotactic Radiosurgery as the initial treatment of non small cell lung cancer patients with limited brain metastases<br>* Other names: Antiangiogenic agents;|
| SBRT group<br>Patients in SBRT group took no anti-angiogenic drugs. All patients received SBRT for brain metastases. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | progression-free survival | 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | overall survival | 1 years | 
| ORR | objective response rate | 3 months | 
| DCR | disease control rate | 3 months | 
| iORR | intracranial objective response rate | 3 months | 
| iPFS | intracranial progression-free survival | 3 months |