Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06969352

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)

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Gliomas Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion and exclusion criteria for treatment group

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
  • 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.
  • 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:

  • Patients who received radiotherapy, chemotherapy or other IDH inhibitors for Glioma before the index date.

Treatment and study plan

Vorasidenib

Drug

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.

Primary outcomes

  1. Primary efficacy endpoint

    Time frame: at 6 months after the index date

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

Secondary outcomes

  1. Secondary efficacy endpoint

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

    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.

  2. Secondary efficacy endpoint

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

    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.

  3. Secondary efficacy endpoint

    Time frame: 30 months

    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.

Sponsors and collaborators

Lead sponsor

Servier (Tianjin) Pharmaceutical Co. LTD.

Industry

Collaborators

  • Clinical TrialService (Guangzhou) Co.,Ltd
  • Fantastic Bioimaging Co., Ltd.
  • Hainan Boyan Medical Research Co. Ltd.
  • Institut de Recherches Internationales Servier (I.R.I.S.)

Registry information

Acronym: VICTORIA

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 13, 2025
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.