Intrathecal PD-1/VEGF Bispecific Antibody Plus Pemetrexed for Leptomeningeal Metastasis

Launched by GUANGZHOU MEDICAL UNIVERSITY · Feb 1, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for leptomeningeal metastasis, a serious condition where cancer spreads to the protective layers of the brain and spinal cord. Researchers are testing a combination of two treatments: a bispecific antibody that targets specific proteins (PD-1 and VEGF) and a chemotherapy drug called pemetrexed. The goal is to see if this combination is safe and effective for patients with solid tumors that have spread to this area.

To participate in the trial, patients need to be between 21 and 75 years old and have a confirmed diagnosis of solid tumors with cancer cells found in their cerebrospinal fluid. They should also have normal liver and kidney function and not have any severe nervous system problems. Participants will receive the new treatment and be closely monitored for its effects and any side effects. This trial is currently recruiting, and it aims to find better treatment options for 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 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. Obvious bleeding tendency; Patients with hemorrhage (NCI-CTCAE v5.0 greater than grade 2), coagulation disorder, hypertensive crisis, and severe arterial thrombosis.
• • 4. 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.
• • 5. 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.
• • 6. Patients with poor compliance or other reasons that were unsuitable for this study.