Actively Recruiting
Intrathecal Dual Checkpoint Inhibitor (PD-1 and CTLA-4) in Combination With Pemetrexed for Leptomeningeal Metastasis
Led by Guangzhou Medical University · Updated on 2025-05-18
34
Participants Needed
2
Research Sites
67 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase I/II study is to evaluate the recommended dose, safety, feasibility, and therapeutic response of intrathecal dual checkpoint inhibitor (targeting PD-1 and CTLA-4 with QL1706) in combination with pemetrexed in patients with leptomeningeal metastasis.
CONDITIONS
Official Title
Intrathecal Dual Checkpoint Inhibitor (PD-1 and CTLA-4) in Combination With 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 of at least 4000/mm3
- Platelet count of 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
- History of HIV or AIDS, acute or chronic hepatitis B or C infection
- Previous pneumonitis caused by anti-PD1 therapy or ongoing adverse events greater than grade 2 from such therapy
- Ongoing autoimmune disease requiring systemic treatment in the past 2 years
- Poor compliance or other reasons making the patient unsuitable for this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
The Affiliated Huizhou Hospital, Guangzhou Medical University
Huizhou, Guangdong, China, 516000
Actively Recruiting
2
The Affiliated Huizhou Hospital, Guangzhou Medical University
Huizhou, Guangdong, China, 516000
Actively Recruiting
Research Team
Z
Zhenyu Pan
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here