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).
Study Type
OBSERVATIONAL
Enrollment
60
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.
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
West China Lecheng Hospital Sichuan University
Qionghai, Hainan, China
West China Hospital Sichuan University
Chengdu, Sichuan, China
Primary efficacy endpoint
TGR at 6 months after the index date\*. TGR is defined as percentage change in tumour volume from baseline.
Time frame: at 6 months after the index date
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.
Time frame: 12 months after the index date of the last required sample patient
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.
Time frame: 12 months after the index date of the last required sample patient
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.