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 | Not Yet Recruiting

• 1 other identifier: S095032-235
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

• Primary efficacy endpoint

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

  at 6 months after the index date

Secondary Outcomes (2)

• Secondary efficacy endpoint

  12 months after the index date of the last required sample patient

• Secondary efficacy endpoint

  12 months after the index date of the last required sample patient

Study Arms (2)

treatment group(Vorasidenib)

As 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.

Drug: Vorasidenib

external control group (untreated after surgery)

Eligible 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.

Interventions

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.

treatment group(Vorasidenib)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The data for the external control group will be retrospectively collected from West China Hospital, Beijing Tiantan Hospital, and other neurosurgical centers, as well as potentially suitable data sources (e.g., the National Brain Tumor Registry Center).

You may not qualify if:

• 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 received radiotherapy, chemotherapy or other IDH inhibitor for Glioma before enrolment.
• Patients with any contrindications to Vorasidenib
• 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.

Sponsors & Collaborators

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

Study Sites (3)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

West China Lecheng Hospital Sichuan University

Qionghai, Hainan, China

Location

West China Hospital Sichuan University

Chengdu, Sichuan, China

Location

MeSH Terms

Conditions

Glioma

Interventions

vorasidenib

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Qiaohui KANG

CONTACT

+8618500350333; qiaohui.kang@servier.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 13, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)