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New spinal fluid treatment targets deadly cancer spread

NCT ID NCT06462222

Disease control Sponsor: Guangzhou Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 21, 2026 · Updated 1 time

Summary

This study tests a new treatment for leptomeningeal metastasis, a condition where cancer spreads to the lining of the brain and spinal cord. The treatment combines an immune checkpoint inhibitor (a drug that helps the immune system fight cancer) with pemetrexed (a chemotherapy drug), both injected directly into the spinal fluid. The study involves 45 adults with solid tumors and aims to find the safest dose and check for side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

45 people

The number who actually took part.

Started

Jun 2024

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of solid tumors; Cerebrospinal fluid cytopathology is positive. 2. Male or female aged between 18 and 75 years; Normal liver and kidney function; WBC≥4000/mm3, Plt≥100000/mm3. 3. No history of severe nervous system disease; No severe dyscrasia. Exclusion Criteria: 1. Any evidence of nervous system failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy on imaging, and Glasgow Coma Score less than 11. 2. Any evidence of extensive and lethal progressive systemic diseases without effective treatment. 3. A history of HIV or AIDS, acute or chronic hepatitis B or C infection, previous anti-PD1 therapy-induced pneumonitis, or have ongoing \>Grade 2 adverse events of such therapy; or ongoing autoimmune disease that required systemic treatment in the past 2 years. 4. Patients with poor compliance or other reasons that were unsuitable for this study.

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Conditions

The condition(s) this trial relates to.

Meningeal Carcinomatosis neoplastic meningitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Leptomeningeal metastasis

Contacts and locations

Locations

  • Beijing Chest Hospital, Capital Medical University

    Beijing, 101100, China

  • Cancer Center, Aerospace Center Hospital, Peking University Aerospace School of Clinical Medicine

    Beijing, China

  • Huizhou First Hospital Affiliated to Guangdong Medical University

    Huizhou, Guangdong, China

  • Jinshan Hospital, Fudan University

    Shanghai, China

  • The Affiliated Huizhou Hospital, Guangzhou Medical University

    Huizhou, Guangdong, 516000, China

More trials for these conditions

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