Actively Recruiting
Intrathecal Combination of Programmed Death-1 (PD-1)/Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4) Bispecific Antibody and Pemetrexed for Leptomeningeal Metastasis
Led by Guangzhou Medical University · Updated on 2025-05-20
36
Participants Needed
1
Research Sites
64 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Leptomeningeal metastasis, characterized by tumor cells infiltrating and proliferating in the subarachnoid space, represents a distinct pattern of central nervous system involvement and is a fatal complication of malignant tumors. This phase I/II study is to evaluate the recommended dose, safety, feasibility, and therapeutic response of intrathecal Programmed Death-1 (PD-1)/Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4) bispecific antibodies combined with pemetrexed in patients with leptomeningeal metastasis.
CONDITIONS
Official Title
Intrathecal Combination of Programmed Death-1 (PD-1)/Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4) Bispecific Antibody and Pemetrexed for Leptomeningeal Metastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed solid tumor diagnosis with positive cerebrospinal fluid cytopathology
- Male or female aged 18 to 75 years
- Normal liver and kidney function
- White blood cell count of at least 4000/mm3
- Platelet count of at least 100000/mm3
- No history of severe nervous system diseases
- No severe blood disorders
You will not qualify if you...
- Evidence of nervous system failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy on imaging, or Glasgow Coma Score below 11
- Extensive and lethal progressive systemic diseases without effective treatment
- History of HIV or AIDS, acute or chronic hepatitis B or C infection
- Previous anti-PD1 therapy causing pneumonitis or ongoing adverse events above Grade 2 from such therapy
- Ongoing autoimmune disease requiring systemic treatment in the past 2 years
- Use of new drugs effective against leptomeningeal metastases during the first month of treatment and induction/consolidation phases, excluding previously used drugs (e.g., EGFR-TKI/ALK-TKI like Osimertinib, Lorlatinib)
- Poor compliance or other reasons making the patient unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Affiliated Huizhou Hospital, Guangzhou Medical University
Huizhou, Guangdong, China, 516000
Actively Recruiting
Research Team
Z
Zhenyu Pan, PhD, MD
CONTACT
G
Guozi Yang, PhD, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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