RecruitingPhase 1NCT06663306

Intrathecal Injection Pemetrexed And Bevacizumab in Patients With Leptomeningeal Metastases in NSCLC

Efficacy and Safety of Pemetrexed Combined With Bevacizumab Intrathecal Injection in Patients With Leptomeningeal Metastases in NSCLC


Sponsor

Shanghai Chest Hospital

Enrollment

19 participants

Start Date

Dec 9, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, single-arm, phase Ia clinical study, which was designed to evaluate the efficacy and safety of Pemetrexed Combined With Bevacizumab Intrathecal Injection in Patients With Leptomeningeal Metastases in NSCLC.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether injecting two cancer drugs — pemetrexed and bevacizumab — directly into the spinal fluid (called intrathecal injection) can help control leptomeningeal metastasis, a serious condition where non-small cell lung cancer has spread to the thin membranes surrounding the brain and spinal cord. **You may be eligible if...** - You are 18 or older and have been diagnosed with non-small cell lung cancer - Your cancer has spread to the brain and spinal membranes (confirmed by spinal fluid analysis or MRI) - Your current standard treatments have not controlled this spread - Your expected survival is at least 1 month - Your blood counts and organ function meet minimum requirements **You may NOT be eligible if...** - You are HIV-positive - You are allergic to pemetrexed or bevacizumab - You have previously received either of these drugs injected into the spinal fluid - You have certain bleeding disorders, serious infections, or other conditions that make this procedure unsafe - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPemetrexed

Intrathecal pemetrexed 50mg,twice per week (d1, d8) for 1 week, then once per 4 weeks

DRUGBevacizumab

Intrathecal bevacizumab, once (d8)for 1 week, then once per 4 weeks.The initial dose of intrathecal bevacizumab is 5 mg, escalated to 10 mg, and then 25 mg, and then 37.5mg, and then 50mg.


Locations(1)

Shanghai Chest Hospital

Shanghai, China

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NCT06663306


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