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| Name | Class |
|---|---|
| Institut de Recherches Internationales Servier (I.R.I.S.) | INDUSTRY |
| Hainan Boyan Medical Research Co. Ltd. | UNKNOWN |
| Fantastic Bioimaging Co., Ltd. | UNKNOWN |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vorasidenib | Drug | Treatment group: recommended dosage in adults and paediatric patients 12 years of age and older:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months after the index date of the last required sample patient |
| Secondary efficacy endpoint |
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Inclusion and exclusion criteria for treatment group
Patients will be included if they meet all the following criteria:
Patients who meet at least one of the following exclusion criteria will not be included in the study:
Inclusion and exclusion criteria for the external control group
Patients will be included if they meet all the following criteria:
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.
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiaohui KANG | Contact | +8618500350333 | qiaohui.kang@servier.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital, Capital Medical University | Beijing | Beijing Municipality | China |
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| Clinical TrialService (Guangzhou) Co.,Ltd |
| UNKNOWN |
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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. |
| 12 months after the index date of the last required sample patient |
| West China Lecheng Hospital Sichuan University | Qionghai | Hainan | China |
|
| West China Hospital Sichuan University | Chengdu | Sichuan | China |
|
| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| C000716758 | vorasidenib |
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