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)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 62
- 试验地点
- 3
- 主要终点
- Primary efficacy endpoint
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion and
排除标准
- •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.
- •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.
研究组 & 干预措施
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.
干预措施: Vorasidenib (Drug)
结局指标
主要结局
Primary efficacy endpoint
时间窗: 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.
次要结局
- Secondary efficacy endpoint(12 months after the index date of the last required sample patient)
- Secondary efficacy endpoint(30 months after the index date of the last required sample patient)
- Secondary efficacy endpoint(30 months)