Brain tumor drug vorasidenib tested in everyday practice

NCT ID NCT06969352

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This study looks at how well the drug vorasidenib works and how safe it is for people with a slow-growing type of brain tumor called grade 2 astrocytoma or oligodendroglioma that has an IDH1 or IDH2 mutation. The study includes people aged 12 and older in China who are treated in regular medical practice, not in a strict research setting. Researchers will measure tumor growth over time and compare results to a group of similar patients who did not receive the drug.

What this could mean

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

Active substance
vorasidenib
What this could lead to
If successful, this study could confirm that vorasidenib effectively slows tumor growth in routine clinical practice, offering a new treatment option for people with these slow-growing brain tumors.
What could go wrong
This is an observational real-world study, not a randomized controlled trial, so results may be less definitive. The small size (62 participants) and lack of mandatory visits could limit data quality.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

62 people

The number who actually took part.

Started

Sep 2025

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

12 years and older

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 and exclusion criteria for treatment group Patients will be included if they meet all the following criteria: 1. Patients (female and male) aged ≥ 12 years at enrolment. 2. Patients with tissue-confirmed diagnoses of Grade 2 astrocytoma or oligodendroglioma with IDH1 or IDH2 mutation 3. Have undergone at least one prior glioma surgery (biopsy, subtotal resection, or complete resection). 4. Patients with evaluable disease based on the most recent MRI in the opinion of the treating physician. A measurable non-enhanced lesion is defined as at least one target lesion with dimensions of ≥1 cm × ≥1 cm (in two dimensions). Confirmed by a centralized IRC as minimal, non-nodular, and non-measurable enhancement. 5. The PI evaluates based on the Vorasidenib label and patients is willing plan to receive Vorasidenib 6. Be able to understand and provide written informed consent if the patient is 18 years or older, or if the patient is a minor (12 years or older and under 18 years), both the patient and their legal representative must sign the informed consent. Patients who meet at least one of the following exclusion criteria will not be included in the study: 1. Patients who received radiotherapy, chemotherapy or other IDH inhibitor for Glioma before enrolment. 2. Patients with any contrindications to Vorasidenib Inclusion and exclusion criteria for the external control group Patients will be included if they meet all the following criteria: 1. Patients (female and male) aged ≥ 12 years at the index date. 2. Patients with tissue-confirmed diagnoses of Grade 2 astrocytoma or oligodendroglioma with IDH1 or IDH2 mutation 3. Have undergone at least one prior glioma surgery (biopsy, subtotal resection, or complete resection) before the index date. 4. Since the index date, the patient must have undergone at least two magnetic resonance imaging (MRI) scans with an interval of at least 6 months (±30 days), showing measurable or evaluable non-enhancing lesions. Measurable non-enhancing lesions are defined as at least one target lesion that is ≥1 cm × ≥1 cm (two-dimensional). These lesions must be centrally confirmed by the IRC (Independent Review Committee) as small, non-nodular, and nonmeasurable enhancing lesions. 6\) Must have at least 6 months (±30 days) follow-up historical data since the index date without any treatment in this period. Patients who meet at least one of the following exclusion criteria will not be included in the study: 1\) Patients who received radiotherapy, chemotherapy or other IDH inhibitors for Glioma before the index date.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality, China

  • West China Hospital Sichuan University

    Chengdu, Sichuan, China

  • West China Lecheng Hospital Sichuan University

    Qionghai, Hainan, China

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