[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611906":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":22,"locations":23,"responsibleParty":41,"collaborators":22,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":22,"eligibilityCriteria":48,"healthyVolunteers":45,"sex":49,"minAge":50,"maxAge":22,"enrollmentInfo":51,"targetDuration":22,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":22,"overallStatus":26,"whyStopped":22,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},{"fullName":5,"class":6},"Yonsei University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Carbon Ion Radiotherapy + Atezolizumab + Bevacizumab","EXPERIMENTAL","Participants will receive standard first-line systemic therapy with atezolizumab (1200 mg IV every 3 weeks) plus bevacizumab (15 mg\u002Fkg IV every 3 weeks). Carbon ion radiotherapy will be integrated as a sequential local treatment during the early phase of systemic therapy.\n\nCarbon ion radiotherapy will be delivered to the primary hepatic tumor using a hypofractionated regimen (approximately 4-12 fractions), with dose and fractionation individualized according to tumor extent, anatomical proximity to gastrointestinal organs, and institutional organ-at-risk constraints.\n\nFollowing completion of carbon ion radiotherapy, participants will continue atezolizumab-bevacizumab maintenance therapy until radiologic disease progression, unacceptable toxicity, or withdrawal of consent. This protocol is designed to enhance local tumor control while preserving the systemic therapeutic benefit of atezolizumab and bevacizumab.",[13],"Radiation: Carbon Ion Radiotherapy Atezolizumab Bevacizumab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"RADIATION","Carbon Ion Radiotherapy Atezolizumab Bevacizumab","Participants will initiate systemic therapy with atezolizumab (1200 mg IV every 3 weeks) and bevacizumab (15 mg\u002Fkg IV every 3 weeks). Carbon ion radiotherapy will subsequently be administered to the primary hepatic lesion during the early phase of systemic therapy.\n\nCarbon ion radiotherapy will be delivered using a hypofractionated schedule (approximately 4-12 fractions), with dose and fractionation individualized based on tumor size, anatomical location, and organ-at-risk considerations. After completion of carbon ion radiotherapy, participants will continue maintenance treatment with atezolizumab and bevacizumab until disease progression or unacceptable toxicity.",[9],[21],"Atezolizumab: Anti-PD-L1 antibody Bevacizumab: Anti-VEGF monoclonal antibody Carbon Ion Radiotherapy: Heavy-ion radiotherapy, C-ion RT",null,[24],{"facility":25,"status":26,"city":27,"state":22,"zip":22,"country":28,"countryCode":22,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"Yonsei University Health System, Severance Hospital","RECRUITING","Seoul","South Korea",{"type":30,"coordinates":31},"Point",[32,33],126.9784,37.566,{"lat":33,"lon":32},[36],{"name":37,"role":38,"phone":39,"phoneExt":22,"email":40},"Ik Jae Lee","CONTACT","+82-2-2228-8117","IKJAE412@YUHS.AC",{"type":42,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100611906","phase-2-a-phase-ii-single-arm-clinical-study-to-evaluate-the-efficacy-and-safety-of-carbon-ion-radiotherapy-with-atezolizumab-and-bevacizumab-combination-therapy-in-patients-with-advanced-hepatocellular-carcinoma-100611906",false,"NCT07246668","A Phase II Single-Arm Clinical Study to Evaluate the Efficacy and Safety of Carbon Ion Radiotherapy With Atezolizumab and Bevacizumab Combination Therapy in Patients With Advanced Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Age ≥ 18 years Histologically or radiologically confirmed hepatocellular carcinoma (HCC) Barcelona Clinic Liver Cancer (BCLC) stage B or C, not eligible for curative surgery or transplantation.\n\nAt least one measurable lesion according to RECIST criteria. Eligible for treatment with atezolizumab plus bevacizumab based on clinical judgment.\n\nCandidate for carbon ion radiotherapy determined by radiation oncologist. Child-Pugh class A liver function Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n\nAdequate organ and marrow function, including:\n\nAbsolute neutrophil count ≥ 1,500\u002FμL Platelet count ≥ 75,000\u002FμL Hemoglobin ≥ 8.5 g\u002FdL Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL\u002Fmin AST\u002FALT ≤ 5 × ULN Total bilirubin ≤ 3 mg\u002FdL No uncontrolled esophageal or gastric varices, confirmed by endoscopy (within 6 months), or adequately treated before enrollment.\n\nAbility to understand and willingness to sign a written informed consent form.\n\nExclusion Criteria:\n\n* Prior systemic therapy with anti-PD-1, anti-PD-L1, or anti-VEGF agents within the past year.\n\nPrior carbon ion radiotherapy to the same anatomical region.\n\nPresence of uncontrolled or severe cardiovascular disease, including:\n\nRecent myocardial infarction (within 6 months) Uncontrolled hypertension NYHA class III-IV heart failure Active or history of autoimmune disease requiring systemic immunosuppressive therapy.\n\nActive infection, including:\n\nUncontrolled bacterial, viral, or fungal infection Active tuberculosis HIV infection, or active hepatitis B\u002FC with uncontrolled viral replication.\n\nSignificant bleeding risk, including:\n\nActive gastrointestinal bleeding Untreated or high-risk varices Coagulopathy not controllable with standard therapy Portal vein tumor thrombosis (PVTT) of grade Vp4 if judged unsuitable for treatment by investigator.\n\nPregnant or breastfeeding women History of organ transplantation, including liver transplantation. Any condition judged by the investigator to interfere with study participation, treatment compliance, or safety evaluation.","ALL","20 Years",{"count":52,"type":53},52,"ESTIMATED","INTERVENTIONAL",[56],"PHASE2","This single-center, prospective phase II clinical trial evaluates the safety and therapeutic efficacy of combining carbon ion radiotherapy with the standard first-line regimen of atezolizumab and bevacizumab in patients with advanced hepatocellular carcinoma. The study aims to determine whether the addition of carbon ion radiotherapy enhances tumor control and improves clinical outcomes beyond those achieved with systemic therapy alone. Key endpoints include overall survival, progression-free survival, objective response rate, and treatment-related adverse events.",[59,60,61,62],"Hepatocellular Carcinoma","Liver Neoplasms","Carcinoma","Hepatocellular","2025-11-17",{"date":65,"type":66},"2025-11-24","ACTUAL",{"date":68,"type":66},"2025-03-10",{"date":70,"type":53},"2028-03",{"name":5,"class":6},1]