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).
None
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 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).
Case-control
Other
Vorasidenib
DrugTreatment 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 efficacy endpoint
TGR at 6 months after the index date\*. TGR is defined as percentage change in tumour volume from baseline.
Secondary efficacy endpoint
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.
Secondary efficacy endpoint
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.
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Servier (Tianjin) Pharmaceutical Co. LTD.
Lead sponsor
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
This trial is not recruiting at the moment. You can still explore other options:
