Intrathecal Combination of Programmed Death-1 (PD-1)/Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4) Bispecific Antibody and Pemetrexed for Leptomeningeal Metastasis

Launched by GUANGZHOU MEDICAL UNIVERSITY · Jan 1, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with leptomeningeal metastasis, a serious condition where cancer spreads to the protective layers surrounding the brain and spinal cord. The researchers are testing a combination of two types of antibodies that target cancer cells, along with a chemotherapy drug called pemetrexed. The goal is to find out if this combination is safe and effective for treating this challenging condition, which can occur in patients with solid tumors.

To participate, individuals must be between 18 and 75 years old and have a confirmed diagnosis of a solid tumor with evidence of cancer cells in their cerebrospinal fluid. They also need to have normal liver and kidney function and no severe neurological issues. If eligible, participants will receive the treatment during the trial and will be monitored closely for any side effects and how well the treatment works. This trial is currently recruiting patients, and those considering participation should discuss it with their healthcare provider for more information.

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. The first month to treatment, as well as during induction and consolidation therapy, new drugs effective against leptomeningeal metastases were used, excluding those previously administered. These primarily included small molecule targeted therapies, such as EGFR-TKI/ALK-TKI drugs like Osimertinib and Lorlatinib.
• • 5. Patients with poor compliance or other reasons that were unsuitable for this study.