SRT Combined With Anlotinib for the Treatment of Brain Metastases From Non-small Cell Lung Cancer: a Single-arm, Prospective, Exploratory Clinical Study
To evaluate the efficacy and safety of SRT combined with anlotinib in the treatment of limited brain metastases from non-small cell lung cancer.
• Patients voluntarily participate in this study, sign informed consent, and demonstrate good compliance.
• Patients with histologically or pathologically confirmed EGFR wild-type and EGFR mutant non-small cell lung cancer resistant to treatment.
• The number of brain metastases is ≤ 5, and the patient has at least one assessable brain metastasis on imaging (RECIST 1.1). Additionally, the patient's physical condition allows for the completion of stereotactic radiosurgery.
• Age between 18-80 years, gender unspecified.
• ECOG performance status of 0 or 1; expected survival of no less than 3 months.
• Regardless of prior treatment, it is only required that concurrent oral administration of anlotinib during radiotherapy without intervention regarding subsequent treatment regimens.
• Oral administration of anlotinib including, but not limited to, third-line therapy.
• Good function of major organs, with laboratory test indicators meeting the following criteria:
∙ <!-- -->
• Hematological examination:
‣ Hemoglobin (Hb) ≥ 90g/L (no blood transfusion within 14 days);
⁃ Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L; total white blood cell count ≥ 3.5×10\^9/L;
⁃ Platelets (PLT) ≥ 100×10\^9/L;
• Blood biochemistry examination:
• a、Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN for liver metastasis/bone metastasis; ≤ 5 ULN for tumor bone metastasis); b、Total bilirubin (TBIL) ≤ 1.5 × ULN; c、Serum creatinine (Cr) ≤ 1.5×ULN or creatinine clearance rate ≥ 60 ml/min;
• Coagulation function examination: Activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5×ULN.