A Phase 3 interventional study of Anlotinib and Whole-brain Radiotherapy in Whole-Brain Radiotherapy, sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-02.
Sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Phase 3, Interventional, and Treatment
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.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences is the lead sponsor of 373 studies on the registry; 270 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Oral Anlotinib plus whole-brain radiotherapy
Drug: Anlotinib · Radiation: Whole-brain Radiotherapy
Only whole-brain radiotherapy
Radiation: Whole-brain Radiotherapy
Oral 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
Prescription 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
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 2 year
CTCs level
Levels of circulating tumor cells (CTCs) in peripheral blood.
Time frame: 1 year
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences