Anlotinib Plus Whole-Brain Radiotherapy for Brain Metastases in SCLC Patients.
Recruiting
Phase 3
Interventional Study
Whole-Brain Radiotherapy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 134 (estimated)
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Other
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About This Trial
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 com…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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…
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