Status:

UNKNOWN

Efficacy and Safety of Recombinant Human Endostatin in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis

Lead Sponsor:

Hui Bu

Conditions:

Leptomeningeal Metastasis

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

The purpose of this study is to observe the clinical effect and safety of Recombinant Human Endostatin in non-small cell lung cancer with leptomeningeal metastasis

Eligibility Criteria

Inclusion

  • Age over 18 years old
  • Pathologically proven non-small cell lung cancer
  • Karnofsky performance status ≥ 40
  • LM diagnosis was based on the detection of malignant cells in the CSF, the focal or diffuse enhancement of leptomeninges, and nerve roots or the ependymal surface on gadolinium-enhanced MRI .
  • No severe abnormal liver and kidney function;
  • Patients have the ability to understand and the willingness to sign a written informed consent document.

Exclusion

  • Evidence of bleeding diathesis or serious infection
  • Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
  • Pregnant or lactating women

Key Trial Info

Start Date :

June 1 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2023

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT04356118

Start Date

June 1 2020

End Date

June 1 2023

Last Update

May 27 2020

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