[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100515493":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":44,"responsibleParty":57,"collaborators":59,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":26,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":90,"overallStatus":46,"whyStopped":26,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Asan Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Radiotherapy combination","EXPERIMENTAL","Atezolizumab+Bevacizumab, combined EBRT to vascular invasion\n\n* Atezolizumab will be administered by IV, 1200 mg on day 1 of each 21day cycle.\n* Bevacizumab will be administered by IV, 15 mg\u002Fkg on day 1 of each 21day cycle.\n* The external beam radiotherapy will commence after day 2 of the first cycle of A+B, and will be delivered in accordance with institutional protocol.",[13],"Radiation: Atezolizumab plus bevacizumab, combined EBRT to vascular invasion",{"label":15,"type":16,"description":17,"interventionNames":18},"Atezolizumab+Bevacizumab","ACTIVE_COMPARATOR","* Atezolizumab will be administered by IV, 1200 mg on day 1 of each 21day cycle.\n* Bevacizumab will be administered by IV, 15 mg\u002Fkg on day 1 of each 21day cycle.",[19],"Drug: Atezolizumab plus bevacizumab",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"RADIATION","Atezolizumab plus bevacizumab, combined EBRT to vascular invasion","The external beam radiotherapy will commence after day 2 of the first cycle of atezolizumab+bevacizumab, and will be delivered in accordance with institutional protocol.\n\n3D-conformal radiotherapy technique is used to determine target volumes, radiation ports, and dose prescriptions by using a 3D radiotherapy planning system.\n\nThe gross tumor volume (GTV) includes vascular invasion and a 2-cm margin into the contiguous HCC. The GTV can consist of the entire HCC and vascular invasion at the discretion of the investigator.\n\nThe target dose is 45 Gy, however, the total dose can be reduced as low as 30 Gy according to the liver function, liver volumes, or the maximum dose to the stomach\u002Fduodenum during the planning process according to the judgment of the radiation oncologist of each participating sites.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DRUG","Atezolizumab plus bevacizumab","Atezolizumab plus bevacizumab q3w",[15],[33],{"name":34,"affiliation":5,"role":35},"Ju Hyun Shim","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Jihyun An","CONTACT","82-31-560-2209","starlit1@naver.com",{"name":34,"role":39,"phone":26,"phoneExt":26,"email":43},"s5854@amc.seoul.kr",[45],{"facility":5,"status":46,"city":47,"state":26,"zip":26,"country":48,"countryCode":26,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Seoul","South Korea",{"type":50,"coordinates":51},"Point",[52,53],126.9784,37.566,{"lat":53,"lon":52},[56],{"name":34,"role":39,"phone":26,"phoneExt":26,"email":26},{"type":35,"investigatorFullName":34,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Principal Investigator",[60,62,64],{"name":61,"class":6},"Seoul National University Hospital",{"name":63,"class":6},"Hanyang University Guri Hospital",{"name":65,"class":6},"Soon Chun Hyang University","100515493","phase-2-atezolizumab-plus-bevacizumab-alone-or-combined-with-external-beam-radiotherapy-for-hcc-with-macrovascular-invasion-100515493",false,"NCT05992220","Atezolizumab Plus Bevacizumab Alone or Combined with External Beam Radiotherapy for HCC with Macrovascular Invasion","A Randomized, Multicenter, Open-Label, Phase II Trial of Atezolizumab Plus Bevacizumab Alone or Combined with External Beam RadioTherapy for HepatoCellular Carcinoma with Macrovascular Invasion (ALERT-HCC)","ALERT-HCC","Inclusion Criteria:\n\n* Older than 19 years of age, lower than 80 years of age\n* Child-Pugh class A hepatic function\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1\n* Patients with HCC \\[diagnosed according to AASLD guidelines\\] invading the intrahepatic vascular system\n* No prior systemic therapy for HCC\n* At least one measurable HCC lesion with ≥ 1cm diameter\n* Adequate hematologic and organ function\n\n  * Hemoglobin ≥ 9.0 g\u002FdL\n  * Absolute neutrophil count ≥ 1,000 \u002Fmm3\n  * Platelet ≥ 50,000\u002F mm3 without transfusion\n* Total bilirubin ≤ 2.5 mg\u002FdL\n\nExclusion Criteria:\n\n* Treatment history of prior systemic treatment of HCC\n* Liver transplant recipients\n* Patients with peptic ulcer, untreated or incompletely treated varices with bleeding or high-risk for bleeding\n* Any serious illness (e.g., active infection or inflammatory condition) or uncontrolled severe medical comorbidity\n* A history of treated malignancy (other than HCC) is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding two years\n* Abdominal\u002Fpelvic radiotherapy within 28 days prior to initiation of study treatment, except palliative radiotherapy to bone lesions within 7 days prior to initiation of study treatment","ALL","20 Years","79 Years",{"count":78,"type":79},138,"ESTIMATED","INTERVENTIONAL",[82],"PHASE2","The recent global IMbrave150 study evaluated the combination of atezolizumab and bevacizumab versus sorafenib in 501 patients with advanced or metastatic Hepatocellular Carcinoma (HCC). The median overall survival (OS) was notably better in the atezolizumab\u002Fbevacizumab group. However, for HCC patients with intrahepatic macrovascular invasion (MVI), the prognosis remains poor, indicating a significant unmet need in this group.\n\nExternal Beam Radiotherapy (EBRT) has shown promising results in treating HCC with MVI, especially when used in combination with trans-arterial chemoembolization (TACE). It has been reported that radiotherapy may make tumor cells more susceptible to immune-mediated therapy, potentially enhancing the effects of atezolizumab and bevacizumab.\n\nThus, this study aims to investigate the efficacy and safety of atezolizumab\u002Fbevacizumab alone versus atezolizumab\u002Fbevacizumab in combination with EBRT in HCC patients with macrovascular invasion.",[85,86,87,88,89],"Hepatocellular Carcinoma","Hepatocellular Cancer","Hepatocellular Carcinoma Non-resectable","Hepatocellular Carcinoma Stage IV","Liver Cancer",[91],"HCC; vascular invasion; portal vein tumor thrombosis; BCLC stage C","2025-02-19",{"date":94,"type":95},"2025-02-21","ACTUAL",{"date":97,"type":95},"2022-10-22",{"date":99,"type":79},"2026-03",{"name":5,"class":6},1]