Actively Recruiting

Phase 3
Age: 18Years - 80Years
All Genders
NCT07443397

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

Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2026-03-02

134

Participants Needed

1

Research Sites

122 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Small cell lung cancer confirmed by pathology with brain metastases diagnosed at initial presentation or during treatment, and measurable disease by RECIST criteria
  • Expected survival time longer than 3 months
  • Intracranial metastases count of 10 or fewer
  • Adequate organ and bone marrow function
  • Women of childbearing potential agree to use effective contraception during the study and for 6 months after completion
Not Eligible

You will not qualify if you...

  • Use of 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
  • Acute or subacute cerebral infarction or intracranial lesion hemorrhage
  • Unresolved acute toxic reactions above grade 2 from prior treatments
  • Advanced disease with severe symptoms, internal organ spread, or high risk of life-threatening complications
  • Life-threatening severe or uncontrolled diseases
  • Previous brain radiotherapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Beijing, Beijing Municipality, China, 100004

Actively Recruiting

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Research Team

L

Lei Deng, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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