RecruitingPhase 3NCT07443397

Anlotinib Plus Whole-Brain Radiotherapy for Brain Metastases in SCLC Patients.

Anlotinib Plus Whole-Brain Radiotherapy for Brain Metastases in Small Cell Lung Cancer Patients: A Multicenter Phase III Trail.


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

134 participants

Start Date

Aug 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of anlotinib (a targeted drug that cuts off blood supply to tumors) and whole-brain radiotherapy for people with small cell lung cancer (SCLC) that has spread to the brain. SCLC is an aggressive type of lung cancer, and brain metastases are a common complication. **You may be eligible if...** - You have small cell lung cancer confirmed by biopsy, with cancer that has spread to the brain - Your cancer is measurable on imaging scans - You have 10 or fewer brain tumors - Your life expectancy is more than 3 months - Your blood counts and organ function are adequate **You may NOT be eligible if...** - You have used anti-angiogenic drugs (blood supply-blocking drugs like anlotinib, bevacizumab) in the last month - Your diagnosis is non-small cell lung cancer - You have lung cancer with bleeding into the airways (hemoptysis) - You have had a recent stroke or brain bleed - You have previously received radiation to the brain - You have other life-threatening or severe uncontrolled health conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAnlotinib

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

RADIATIONWhole-brain Radiotherapy

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.


Locations(1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College

Beijing, Beijing Municipality, China

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NCT07443397


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