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Taking people in ChinaPhase 1/2

Tests methotrexate vesicles injected into spinal fluid for lung cancer spread

Tests methotrexate vesicles injected into spinal fluid in adults with lung cancer.

Key facts

Who runs it
Henan Cancer Hospital
Where
Zhengzhou, ChinaSee the site
Trial code
Registry title
Exploration of the Application of Methotrexate-loaded Drug Vesicles in Intrathecal Injection for Meningeal Metastasis of Lung Cancer
Status
Recruiting
Phase
Phase 1/2
People taking part
14 people, planned
Started
8 Sept 2025
Expected to end
31 Dec 2027
Type of study
Interventional
Treatments tested
  • Methotrexate-loaded vesicles
Record updated
30 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with lung cancer that has spread to the membranes around the brain and spinal cord, and whose standard treatment has failed.

Age
18 years or older
Sex
All sexes can join
Disease stage
Advanced lung cancer with spread to the meninges (membranes around the brain and spinal cord), shown by tumor cells in the cerebrospinal fluid. ECOG PS 0 - 3.
Earlier treatment
Standard treatment must have failed.
Biomarker or test result
Tumor cells must be found in the cerebrospinal fluid test. Lung cancer must be confirmed by biopsy or cytology.

Main reasons for not taking part

  • Infection of the central nervous system at the same time
  • ECOG PS 4 or higher
  • Taking part in another interventional study
  • Severe immunodeficiency disease, now or in the past
  • Any other condition that the researcher judges makes taking part unfit

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • -
  • Participants can be enrolled in this study only if they meet all of the following inclusion criteria:
  • Age ≥ 18 years old
  • Diagnosed with lung cancer by pathological biopsy or cytology
  • Diagnosed with meningeal metastasis by detecting tumor cells in cerebrospinal fluid cytology
  • Patients with advanced lung cancer and meningeal metastasis who have failed standard treatment
  • ECOG PS 0 - 3

Who cannot take part

  • Concurrent central nervous system infectious diseases
  • The following conditions will disqualify a patient from participating in this study:
  • History of or current severe immunodeficiency diseases
  • Any other conditions that, in the judgment of the researcher, make the patient unfit to participate in this study
  • -
  • ECOG PS ≥ 4
  • Patients currently participating in other interventional studies

Where in China

  • Wang QimingZhengzhou, ChinaContact: Wang Qiming, PhDTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

The study consists of two phases: Phase I employs an accelerated titration combined with a "3+3" dose-escalation design to determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D). Phase II further assesses the objective response rate (ORR) at the RP2D. Key secondary endpoints include progression-free survival (PFS), overall survival (OS), and safety profile.

Approximately 10-20 patients with cytologically confirmed leptomeningeal metastasis (age ≥18 years, ECOG PS 0-3) will be enrolled. Participants will receive intrathecal MTX-MPs on days 1, 3, and 5 of the first cycle, followed by once every 3 weeks (Q3W) until disease progression, unacceptable toxicity, or death.

Tumor response will be evaluated using the Response Assessment in Neuro-Oncology (RANO) criteria for leptomeningeal metastasis, and adverse events will be graded according to CTCAE version 5.0. This exploratory study may provide a novel local therapeutic approach for leptomeningeal metastasis from lung cancer.

Treatments tested

  • Methotrexate-loaded vesicles

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase I/II, Single-arm, Single-center Clinical Study: Exploration of the Application of Methotrexate-loaded Drug Vesicles in Intrathecal Injection for Meningeal Metastasis of Lung Cancer
Plain-language title
Tests methotrexate vesicles injected into spinal fluid for lung cancer spreadGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
30 April 2026