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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)

NCT06969352 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-05-13

No results posted yet for this study

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, 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

Interventions

DRUG

Vorasidenib

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.

Sponsors & Collaborators

  • Institut de Recherches Internationales Servier (I.R.I.S.)

    collaborator INDUSTRY

  • Hainan Boyan Medical Research Co. Ltd.

    collaborator UNKNOWN

  • Fantastic Bioimaging Co., Ltd.

    collaborator UNKNOWN

  • Clinical TrialService (Guangzhou) Co.,Ltd

    collaborator UNKNOWN

  • Servier (Tianjin) Pharmaceutical Co. LTD.

    lead INDUSTRY

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2026-10-31
Completion
2027-02-28

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06969352 on ClinicalTrials.gov