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)

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Servier (Tianjin) Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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

• Gliomas

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-10-01
• Completion: 2027-02-01
• First posted: 2025-05-13
• Last updated: 2025-05-13

Locations

3 sites across 1 country: China