Intrathecal Dual Checkpoint Inhibitor (PD-1 and CTLA-4) in Combination With Pemetrexed for Leptomeningeal Metastasis

Launched by GUANGZHOU MEDICAL UNIVERSITY · Feb 1, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment for patients with leptomeningeal metastasis, a condition where cancer spreads to the protective layers of the brain and spinal cord. The researchers want to see if combining two types of immune therapy, called checkpoint inhibitors, with a chemotherapy drug named pemetrexed can be safely given directly into the spinal fluid. The main goals of the study are to find out if this treatment is safe, how well it works, and if patients can tolerate it without severe side effects.

To participate, patients must be between 21 and 75 years old and have a confirmed diagnosis of solid tumors along with certain health criteria, such as normal liver and kidney function. They should not have severe nervous system problems or other serious health conditions that could affect their participation. If eligible, participants will receive the treatment and be monitored for its effectiveness and any side effects. This trial is currently recruiting, and all genders are welcome to apply.

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 21 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.