[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Servier (Tianjin) Pharmaceutical Co. LTD.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":59},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,38],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":26,"lastUpdatePostDateStruct":27,"startDateStruct":30,"completionDateStruct":32,"leadSponsor":34,"locationsCount":37},"100590587","a-multicentre-retrospective-prospective-real-world-study-to-evaluate-the-effectiveness-and-safety-of-vorasidenib-in-patients-with-isocitrate-dehydrogenase-idh12-mutant-grade-2-astrocytoma-or-oligodendroglioma-victoria-study-100590587",false,"NCT06969352","A Multicentre, Retrospective-prospective Real-world Study: to Evaluate the Effectiveness and Safety of Vorasidenib in Patients With Isocitrate Dehydrogenase IDH1\u002F2 Mutant Grade 2 Astrocytoma or Oligodendroglioma (VICTORIA Study)","VICTORIA","Inclusion and exclusion criteria for treatment group\n\nPatients will be included if they meet all the following criteria:\n\n1. Patients (female and male) aged ≥ 12 years at enrolment.\n2. Patients with tissue-confirmed diagnoses of Grade 2 astrocytoma or oligodendroglioma with IDH1 or IDH2 mutation\n3. Have undergone at least one prior glioma surgery (biopsy, subtotal resection, or complete resection).\n4. 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.\n5. The PI evaluates based on the Vorasidenib label and patients is willing plan to receive Vorasidenib\n6. 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.\n\nPatients who meet at least one of the following exclusion criteria will not be included in the study:\n\n1. Patients who received radiotherapy, chemotherapy or other IDH inhibitor for Glioma before enrolment.\n2. Patients with any contrindications to Vorasidenib\n\nInclusion and exclusion criteria for the external control group\n\nPatients will be included if they meet all the following criteria:\n\n1. Patients (female and male) aged ≥ 12 years at the index date.\n2. Patients with tissue-confirmed diagnoses of Grade 2 astrocytoma or oligodendroglioma with IDH1 or IDH2 mutation\n3. Have undergone at least one prior glioma surgery (biopsy, subtotal resection, or complete resection) before the index date.\n4. 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.\n\n6\\) Must have at least 6 months (±30 days) follow-up historical data since the index date without any treatment in this period.\n\nPatients who meet at least one of the following exclusion criteria will not be included in the study:\n\n1\\) Patients who received radiotherapy, chemotherapy or other IDH inhibitors for Glioma before the index date.","ALL","12 Years",{"count":19,"type":20},60,"ESTIMATED","OBSERVATIONAL","The goal of this Study is to evaluate the effectiveness and safety of Vorasidenib in Patients with Isocitrate dehydrogenase IDH1\u002F2 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:\n\nif 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.\n\nThis study is a multicenter, retrospective-and prospective real-world study, There are treatment group (Vorasidenib) and external control group (untreated after surgery).",[24],"Gliomas","NOT_YET_RECRUITING","2025-05-07",{"date":28,"type":29},"2025-05-13","ACTUAL",{"date":31,"type":20},"2025-06",{"date":33,"type":20},"2027-02",{"name":35,"class":36},"Servier (Tianjin) Pharmaceutical Co. LTD.","INDUSTRY",3,{"id":39,"slug":40,"hasResults":11,"nctId":41,"briefTitle":42,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":16,"minAge":45,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":48,"conditions":49,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":4},"100568976","a-multi-center-single-arm-prospective-non-interventional-study-to-investigate-the-safety-profiles-and-effectiveness-of-liposomal-irinotecan-onivyde-in-combination-with-5-fluorouracil-5-fu-and-leucovorin-lv-in-chinese-patients-with-metastatic-pancreatic-cancer-as-approval-condition-seopac-100568976","NCT06688240","A Multi-center, Single-arm, Prospective Non-interventional Study to Investigate the Safety Profiles and Effectiveness of Liposomal Irinotecan (ONIVYDE®) in Combination with 5-fluorouracil (5-FU) and Leucovorin (LV) in Chinese Patients with Metastatic Pancreatic Cancer As Approval Condition (SEOPAC)","SEOPAC","Inclusion Criteria:\n\n* The adult patient (≥18 years of age) has given written informed consent to participate in the study.\n* The patient has been prescribed for ONIVYDE treatment according to the ONIVYDE China mainland SmPC.\n* Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas.\n* Documented metastatic disease.\n* Patient deemed not eligible or failed previous treatment with gemcitabine or gemcitabine containing therapy.\n\nExclusion Criteria:\n\n* Patients who have experienced a severe hypersensitivity reaction to ONIVYDE or Irinotecan HCL.\n* Patients with new or progressive dyspnea, cough, and fever, pending diagnostic evaluation or confirmed diagnostic of interstitial lung disease.\n* Pregnant or nursing (lactating) women.\n* Patients without highly effective methods of contraception during study treatment until 3 months after the last dose of the study drug, Specially,7 months for women of childbearing potential and 4 months for male with partners of childbearing potential after the last dose of the study drug.\n* Other additional exclusions may be applied by the investigator according to the contexts, in order to ensure that the study population will be non-interventional but representative of all eligible subjects.","18 Years",{"count":47,"type":20},120,"The aim of this phase 4 study is to evaluate the safety profile of ONIVYDE in China mainland.\n\nPrimary objective\n\nTo characterize the safety of ONIVYDE when used under standard clinical practice in China mainland on the following aspects:\n\n1. Quantify the rate of grade ≥3 neutropenia (primary objective)\n2. Serious adverse events and serious adverse drug reactions\n3. Adverse events and adverse drug reactions Secondary objective To describe effectiveness in patients receiving ONIVYDE in combination with 5-FU and leucovorin for the treatment of metastatic pancreatic cancer under standard clinical care in China mainland.\n\n(1) Overall survival (2) Overall response (3) Progression free survival (4) Quality of life assessment",[50],"Metastatic Pancreatic Cancer","2024-11-13",{"date":53,"type":29},"2024-11-14",{"date":55,"type":20},"2024-11",{"date":57,"type":20},"2027-07",{"name":35,"class":36},""]