Actively Recruiting
Efficacy and Safety of Intraventricule Pemetrexed Disodium Administered Via Ommaya Reservoir
Led by Xiangya Hospital of Central South University · Updated on 2024-05-06
64
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
Sponsors
X
Xiangya Hospital of Central South University
Lead Sponsor
F
First People's Hospital of Chenzhou
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a open-label, multi-center prospective observation study for the efficacy and safety of intraventricle pemetrexed disodium via ommaya reservoir in the treatment of leptomeningeal metastasis with lung cancer who have failed at least one targeted therapy. In detail: At least the treatment failure was after third-generation EGFR-TKIs in EGFR-mutated lung cancer; or at least the treatment failure was after second-generation ALK-TKIs in ALK-mutated lung cancer; or at least the treatment failure was after one-line of targeted-TKIs in ROS1-mutated non-squamous non-small lung cancer.
CONDITIONS
Official Title
Efficacy and Safety of Intraventricule Pemetrexed Disodium Administered Via Ommaya Reservoir
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of non-squamous non-small cell lung cancer with EGFR, ALK, or ROS1 genetic mutations
- Diagnosis of type I meningeal metastatic carcinoma confirmed by cerebrospinal fluid cytology or biopsy
- Failure of at least third-generation EGFR-TKIs for EGFR mutations, second-generation ALK inhibitors for ALK mutations, or one line of ROS1 inhibitors for ROS1 mutations
- No contraindications to Ommaya capsule implantation
- Women capable of pregnancy must agree to use reliable contraception during the trial; men with partners capable of pregnancy must also agree to use reliable contraception
- Able and willing to provide informed consent and comply with study visits, treatments, and laboratory tests
You will not qualify if you...
- Patients with high viral load of hepatitis B or positive HBcAb without effective anti-HBV treatment
- Human immunodeficiency virus (HIV) infection
- Significant or symptomatic extracranial lesion progression not effectively treatable
- Severe emaciation or cachexia
- Extensive brain lesions with severe symptoms not effectively treatable
- Active other malignant tumors under treatment
- Received or planned to receive live vaccines within 30 days before consent
- Conditions affecting safety or compliance including severe heart failure, unstable angina, recent myocardial infarction, active infections needing systemic therapy, severe organ dysfunction, low blood counts, severe bleeding, or abnormal liver function
- Known hypersensitivity to pemetrexed or history of serious adverse reactions to it
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Xiangya Hospital Central South University
Changsha, Hunan, China, 410008
Actively Recruiting
Research Team
B
bin Li, doctor
CONTACT
X
xiangping Li, pharmacist
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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