Immune Checkpoint Inhibitor Combined With Pemetrexed Intrathecal Injection for Leptomeningeal Metastasis From Solid Tumors

Launched by GUANGZHOU MEDICAL UNIVERSITY · Jun 12, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for patients with leptomeningeal metastasis, which is a type of cancer that spreads to the membranes surrounding the brain and spinal cord. The trial is testing a combination of an immune checkpoint inhibitor—a type of drug that helps the immune system fight cancer—together with pemetrexed, an injection given directly into the spinal fluid. The main goal is to see if this combination is safe and effective for treating patients with solid tumors that have spread to the central nervous system.

To participate in this trial, patients must be between 18 and 75 years old, have a confirmed diagnosis of a solid tumor, and have specific blood test results showing normal liver and kidney function. However, those with severe nervous system issues or certain other health conditions will not be eligible. Participants will receive the experimental treatment and will be closely monitored throughout the study. This trial is currently recruiting, and it offers hope for new treatment options for individuals facing this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Histologically or cytologically confirmed diagnosis of solid tumors; Cerebrospinal fluid cytopathology is positive.
• • 2. Male or female aged between 18 and 75 years; Normal liver and kidney function; WBC≥4000/mm3, Plt≥100000/mm3.
• • 3. No history of severe nervous system disease; No severe dyscrasia.
• Exclusion Criteria:
• • 1. Any evidence of nervous system failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy on imaging, and Glasgow Coma Score less than 11.
• • 2. Any evidence of extensive and lethal progressive systemic diseases without effective treatment.
• • 3. A history of HIV or AIDS, acute or chronic hepatitis B or C infection, previous anti-PD1 therapy-induced pneumonitis, or have ongoing \>Grade 2 adverse events of such therapy; or ongoing autoimmune disease that required systemic treatment in the past 2 years.
• • 4. Patients with poor compliance or other reasons that were unsuitable for this study.