Exploration of the Application of Methotrexate-loaded Drug Vesicles in Intrathecal Injection for Meningeal Metastasis of Lung Cancer
Recruiting
Phase 1
Phase 2
Interventional Study
Leptomeningeal Metastasis From Lung Cancer
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 14 (estimated)
- Sponsor
- Henan Cancer Hospital · Government
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About This Trial
This is a phase I/II, single-arm, open-label, single-center clinical trial to evaluate the safety, tolerability, and preliminary efficacy of intrathecal injection of methotrexate-loaded autologous tumor cell-derived microparticles (MTX-MPs) in patients with leptomeningeal metastasis from lung cancer who have failed standard of care.
The study consists of two phases: Phase I employs an accelerated…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
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Participants can be enrolled in this study only if they meet all of the following inclusion criteria:
1. Age ≥ 18 years old;
2. Diagnosed with lung cancer by pathological biopsy or cytology;
3. Diagnosed with meningeal metastasis by detecting tumor cells in cerebrospinal fl…
Contacts
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