This study is a multicenter, randomized, prospective Phase III study to evaluate the efficacy and safety of anlotinib plus whole-brain radiotherapy (WBRT) compared with WBRT alone in small cell lung cancer (SCLC) patients with brain metastases. Additionally, by investigating the association between changes in circulating tumor cell (CTC) levels in peripheral blood and treatment response to the combination of targeted therapy and radiotherapy, we aim to identify a patient subgroup most likely to benefit from this regimen, as well as potential biomarkers predictive of treatment efficacy.
Small cell lung cancer confirmed by pathology, with brain metastases diagnosed either at initial presentation or during treatment, and measurable disease according to RECIST criteria.
The expected survival time is more than 3 months.
Intracranial metastases ≤10.
Adequate organ and bone marrow function.
Patients who have used antiangiogenic drugs within the previous 1 month.
Non-small cell lung cancer (including combined small cell carcinoma).
Small cell lung cancer with hilar invasion or hemoptysis.
Patients with intracranial acute, subacute cerebral infarction, intracranial lesions acute, subacute hemorrhage.
Parallel
Anlotinib
DrugOral anlotinib treatment was started 2 weeks before radiotherapy for brain metastases, stopped for 1 week after 2 weeks, and continued after radiotherapy until tumor progression
Whole-brain Radiotherapy
RadiationPrescription dose: Whole-brain irradiation with a minimum of 30 Gy in 10 fractions or 36 Gy in 20 fractions. Lesions larger than 5 mm in diameter may receive a simultaneous or sequential boost.
Intracranial progression-free survival
Time from enrollment to intracranial tumor progression or death
Intracranial objective response rate (ORR) and disease control rate (DCR)
ORR (Objective Response Rate): The proportion of patients whose tumors shrink significantly (either completely or partially) after treatment. DCR (Disease Control Rate): The proportion of patients whose tumors either shrink or remain stable (i.e., do not progress) after treatment.
Duration of intracranial response (DOR)
The length of time from when a patient first achieves tumor response (CR or PR) until disease progression or death.
Overall Survival (OS)
The time from enrollment to death from any cause was calculated as the time of death. For participants who were lost to follow-up, the time of death was usually the time of the last follow-up.
CTCs level
Levels of circulating tumor cells (CTCs) in peripheral blood.
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