Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06611657

Antirotinib Hydrochloride Plus Whole Brain Radiotherapy for Small Cell Lung Cancer With Brain Metastases

The objective of this study was to evaluate the efficacy and safety of whole brain radiotherapy combined with antirotinib hydrochloride in the treatment of brain metastases in small cell lung cancer

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

About this study

This was a single-center, single-arm trail. Enrolled patients were pathologically diagnosed with small cell lung cancer and had completed at least 4 cycles of first-line chemotherapy. Patients with brain metastases at first visit or during treatment were treated with whole brain radiotherapy combined with anlotinib hydrochloride. Oral antirotinib was started 2 weeks before radiotherapy for brain metastases and stopped for 1 week after 2 weeks. After radiotherapy, antirotinib was continued until tumor progression. Efficacy and toxicity data were collected for evaluation and analysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Small cell lung cancer confirmed by pathology, completion of at least 4 cycles of first-line chemotherapy, 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.

Exclusion criteria

  • Patients who have used antiangiogenic drugs within the previous 1 month.
  • Non-small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer).
  • 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.

Treatment and study plan

Antirotinib hydrochloride

Drug

Oral antirotinib treatment was started 2 weeks before radiotherapy for brain metastases, stopped for 1 week after 2 weeks, and continued after radiotherapy until tumor progression

Other names: Anlotinib hydrochloride + Brain radiotherapy

Primary outcomes

  1. Intracranial progression-free survival

    Time frame: 6 months

    Time from enrollment to intracranial tumor progression or death

Secondary outcomes

  1. Overall Survival

    Time frame: 1 year

    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.

  2. progression-free survival

    Time frame: 6 months

    The time from enrollment to tumor progression (any aspect) or death from any cause

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

Anlotinib Hydrochloride Combined With Whole Brain Radiotherapy for the Treatment of Brain Metastases in Small Cell Lung Cancer

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Sep 25, 2024
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.