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Brain cancer trial adds spinal-fluid chemo to standard therapy

NCT ID NCT07193654

Disease control Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding a chemotherapy drug (thiotepa) directly into the spinal fluid can help people with glioblastoma that has invaded the brain's ventricles or lining. Participants will first have surgery to remove as much tumor as possible, then receive radiation, oral temozolomide, and the spinal-fluid injections. The goal is to see if this combination improves how long people live without the cancer growing. The trial is currently recruiting 38 adults aged 18–75.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
thiotepa (given into the spinal fluid) and temozolomide (oral chemotherapy)
What this could lead to
If it works, this could offer a new treatment option for people with glioblastoma that has spread to the brain's lining or fluid spaces, potentially improving survival.
What could go wrong
This is a small, early-phase study with only 38 participants and no comparison group. The added thiotepa may cause serious side effects like infection or nerve damage, and it is not yet proven to help.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 38 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Apr 2028

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: * Aged 18 - 75, any gender. * Newly diagnosed WHO grade 4 brain tumor with at least one evaluable lesion, imaging suggesting ventricular or meningeal invasion. * History of intraoperative intraventricular or cisternal opening. * Malignant cells found in cerebrospinal fluid pre-radiotherapy. * ECOG score 0 - 2, expected survival≥3 months. * Stable neurological symptoms for over 7 days. * Neutrophil count≥1.5×10⁹/L, hemoglobin≥90 g/L, platelet count≥75×10⁹/L. * PT/INR and PTT≤1.5×upper limit of normal. * Total bilirubin≤1.5×upper limit of normal, AST and ALT≤1.5×upper limit of normal, albumin≥30 g/L, creatinine≤2×upper limit of normal, calculated or 24-hour urine creatinine clearance rate≥50 mL/min. * Agree to effective contraception from first to 3 months after last dose. Exclusion Criteria: * Pregnant or breastfeeding women. * Active infection within 7 days before starting study drug requiring IV antibiotics or therapeutic warfarin. * Other malignancies in past 5 years. * HIV/AIDS history; past immunodeficiency, or active autoimmune disease needing systemic treatment. * Severe medical, neurological, or psychiatric conditions preventing full adherence to study treatment or assessments. * Ventricular drainage tube rupture or inability to undergo lumbar puncture. * Uncontrolled chronic diseases like diabetes, CHF, liver cirrhosis, or CKD.

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Conditions

The condition(s) this trial relates to.

glioblastoma Meningeal Carcinomatosis

As listed by the trial registrant

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

Glioblastoma (GBM)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • 2nd Affiliated Hospital, School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310000, China

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