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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Anlotinib
  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
• Лучевая терапия Whole-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.

Первичные конечные точки

• Intracranial progression-free survival [Срок оценки: 1 year]

Вторичные конечные точки (4)

• Intracranial objective response rate (ORR) and disease control rate (DCR) [Срок оценки: 1 year]
• Duration of intracranial response (DOR) [Срок оценки: 1 year]
• Overall Survival (OS) [Срок оценки: 2 year]
• CTCs level [Срок оценки: 1 year]

Критерии участия

Критерии включения

• 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.
• Women of childbearing potential must agree to use effective contraception during the study and for 6 months after its completion.

Критерии исключения

• 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.
• An unresolved acute toxic reaction period higher than grade 2 of CTC-AE(4.0) due to any prior treatment.
• Advanced patients with severe symptoms, tumors that have spread to the internal organs, and a short-term risk of life-threatening complications.
• Patients with life-threatening conditions of other severe and/or uncontrolled diseases.
• History of prior brain radiotherapy.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• National Cancer Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Unio — Пекин

Идентификаторы

NCT: NCT07443397 · NCC5213

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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