A Phase I/II, Single Arm, Single Center Clinical Study: Exploration of the Application of Intrathecal Injection of Methotrexate loaded Vesicles in Lung Cancer Meningeal Metastasis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500108405

Enrollment

Unknown

Registered

2025-08-29

Start date

2025-09-01

Completion date

Unknown

Last updated

2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer Meningeal Metastasis

Interventions

Experimental group: intrathecal injection of methotrexate loaded drug vesicles

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years old; 2. Diagnosed with lung cancer through pathological biopsy or cytology; 3. Cytological examination of cerebrospinal fluid revealed that tumor cells were diagnosed with meningeal metastasis; 4. Late stage lung cancer patients with meningeal metastasis who have failed standard treatment; 5 ECOG PS 0-3.

Exclusion criteria

Exclusion criteria: 1. Infectious diseases of central nervous system; 2. ECOG PS >= 4; 3. Patients who are currently participating in other intervention studies; 4. Previously or currently suffering from severe immunodeficiency diseases; 5. According to the researcher's determination, the patient is not suitable to participate in any other circumstances of this study.

Design outcomes

Primary

Measure	Time frame
Effectiveness indicator: Objective response rate (ORR);Explore MTD and RP2D;	—

Secondary

Measure	Time frame
Safety indicators: including the types, frequency, and severity of adverse events.;	—

Countries

China

Contacts

Public ContactQiming Wang

Henan Cancer Hospital

qimingwang1006@126.com+86 137 8359 0691

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026