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GliomasVICTORIANCT06969352

A Multicentre, Retrospective-prospective Real-world Study: to Evaluate the Effectiveness and Safety of Vorasidenib in Patients With Isocitrate Dehydrogenase IDH1/2 Mutant Grade 2 Astrocytoma or Oligodendroglioma (VICTORIA Study)

A study testing Vorasidenib in people with Gliomas, run by Servier (Tianjin) Pharmaceutical Co. LTD. at 3 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this Study is to evaluate the effectiveness and safety of Vorasidenib in Patients with Isocitrate dehydrogenase IDH1/2 mutant Grade 2 astrocytoma or oligodendroglioma, primary purposeis to evaluate the efficectiveness of Vorasidenib in glioma patients treated in routine clinical practice in In China… Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Gliomas
What is being tested?
Vorasidenib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
3 sitesChina
Study dates
2 Sep 2025to Apr 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients will be included if they meet all the following criteria:
  • Patients (female and male) aged ≥ 12 years at enrolment.
  • Patients with tissue-confirmed diagnoses of Grade 2 astrocytoma or oligodendroglioma with IDH1 or IDH2 mutation
  • Have undergone at least one prior glioma surgery (biopsy, subtotal resection, or complete resection).
  • 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.
  • The PI evaluates based on the Vorasidenib label and patients is willing plan to receive Vorasidenib
Show all 19Show fewer
  • 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:
  • Patients who received radiotherapy, chemotherapy or other IDH inhibitor for Glioma before enrolment.
  • 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:
  • Patients (female and male) aged ≥ 12 years at the index date.
  • Patients with tissue-confirmed diagnoses of Grade 2 astrocytoma or oligodendroglioma with IDH1 or IDH2 mutation
  • Have undergone at least one prior glioma surgery (biopsy, subtotal resection, or complete resection) before the index date.
  • 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.

Who cannot join

None listed.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • West China Hospital Sichuan University

    Chengdu, Sichuan

  • West China Lecheng Hospital Sichuan University

    Qionghai, Hainan

Other trials in China

About this study

The goal of this Study is to evaluate the effectiveness and safety of Vorasidenib in Patients with Isocitrate dehydrogenase IDH1/2 mutant Grade 2 astrocytoma or oligodendroglioma, primary purposeis to evaluate the efficectiveness of Vorasidenib in glioma patients treated in routine clinical practice in In China, patients aged 12 and above with grade II or higher astrocytoma or oligodendroglioma with IDH1 or IDH2 mutations. The main question it aims to answer is:

if this trend is consistent with the efficacy observed in the INDIGO study, and there is not any new safety signal compared to previous research data? Researchers will compare to no treatment. Participants is not mandatory for a formal visit as it is a real-word study.However, due to the fact that patients will be treated with new drugs and need to collect data on major efficacy, regular visits should be performed in routine clinical practice.

This study is a multicenter, retrospective-and prospective real-world study, There are treatment group (Vorasidenib) and external control group (untreated after surgery).

Conditions
Gliomas
Being tested
Vorasidenib
Medical subject headings
Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VorasidenibDrug

    Treatment group: recommended dosage in adults and paediatric patients 12 years of age and older:

    • For patients weighing at least 40 kg: 40 mg, orally, once daily.
    • For patients weighing less than 40 kg: 20 mg, orally, once daily.
Study groups in NCT06969352
Study groupRoleWhat they receive
treatment group(Vorasidenib)ExperimentalAs a real-world study, in principle, a formal visit is not mandatory. However, due to the fact that patients will be treated with new drugs and need to collect data on major efficacy, regular visits should be performed in routine clinical practice.
Receives: Drug: Vorasidenib
external control group (untreated after surgery)No interventionEligible patients are those who have MRI data available for analysis after glioma surgery (including biopsy, subtotal resection, or total resection) and at least one additional MRI scan available for analysis within the following 6 months after the index data During this period, the eligible patients who have not undergone radiotherapy or chemotherapy after resection will be included in the external control arm.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary efficacy endpoint

    TGR at 6 months after the index date*. TGR is defined as percentage change in tumour volume from baseline.

    Measured: at 6 months after the index date

Secondary outcomes (3)

  1. Secondary efficacy endpoint

    TTNI, TTNI is defined as the time from enrolment to the initiation of the first subsequent anticancer therapy or death due to any causes whichever occurs earlier.

    Measured: 30 months after the index date of the last required sample patient

  2. Secondary efficacy endpoint

    rwPFS, defined as the time from enrolment to physician-documented disease progression or date of death due to any cause, whichever occurs earlier, evaluated according to the modified RANO-LGG.

    Measured: 30 months after the index date of the last required sample patient

  3. Secondary efficacy endpoint

    TGR every 6 months after the index date, defined as the percentage change in tumor volume every 6 months after the index date in the Vorasidenib treatment group, as assessed per IRC.

    Measured: 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2025
  2. Study start2 Sep 2025
  3. Primary completionApr 2028 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06969352
Sponsor's protocol ID
S095032-235
Acronym
VICTORIA
Status last verified
Jul 2026
First submitted
29 Apr 2025
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Vorasidenib in people with Gliomas, run by Servier (Tianjin) Pharmaceutical Co. LTD. at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary efficacy endpoint (time frame: at 6 months after the index date). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06969352.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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