Actively Recruiting
Intrathecal PD-1/VEGF Bispecific Antibody Plus Pemetrexed for Leptomeningeal Metastasis
Led by Guangzhou Medical University · Updated on 2025-05-20
34
Participants Needed
1
Research Sites
58 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 PD-1/VEGF bispecific antibody plus pemetrexed in patients with leptomeningeal metastasis.
CONDITIONS
Official Title
Intrathecal PD-1/VEGF Bispecific Antibody Plus Pemetrexed for Leptomeningeal Metastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed diagnosis of solid tumors with positive cerebrospinal fluid cytopathology
- Male or female aged between 21 and 75 years
- Normal liver and kidney function
- White blood cell count at least 4000/mm3
- Platelet count at least 100000/mm3
- No history of severe nervous system disease
- 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 less than 11
- Extensive and lethal progressive systemic diseases without effective treatment
- Bleeding tendency, hemorrhage greater than grade 2, coagulation disorders, hypertensive crisis, or severe arterial thrombosis
- History of HIV/AIDS or acute/chronic hepatitis B or C infection
- Previous anti-PD1 therapy-induced pneumonitis or ongoing grade 2 or higher adverse events from such therapy
- Ongoing autoimmune disease requiring systemic treatment in the past 2 years
- Use of new drugs effective against leptomeningeal metastases within the first month of treatment or during induction and consolidation therapy, excluding previously administered drugs
- Poor compliance or other reasons 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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