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Rico",{"type":54,"coordinates":588},[589,590],-66.04989,18.39745,{"lat":590,"lon":589},{"type":593,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100523522",false,"NCT06096779","A Study Evaluating Atezolizumab, With or Without Bevacizumab, in Participants With Unresectable Hepatocellular Carcinoma and Child-pugh B7 and B8 Cirrhosis","A Phase II, Open-label, Multi-cohort, Multicenter Study in Patients With Unresectable Hepatocellular Carcinoma and Child-pugh B7 and B8 Cirrhosis","Kirros","General Inclusion Criteria:\n\n* Locally advanced or metastatic and\u002For unresectable HCC with diagnosis confirmed by histology\u002Fcytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic participants\n* Disease that is not amenable to curative surgical and\u002For locoregional therapies\n* No prior systemic treatment (including systemic investigational agents) for locally advanced or metastatic and\u002For unresectable HCC\n* Measurable disease (at least one untreated target lesion) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 7 days prior to initiation of study treatment\n* Child-pugh B7 or B8 cirrhosis at screening and within 7 days prior to study treatment\n* Adequate hematologic and end-organ function\n* Life expectancy of at least 12 weeks\n* Female participants of childbearing potential must be willing to avoid pregnancy and egg donation\n* Absolute neutrophil count ≥1.0 x 10\\^9 per liter (\u002FL) (≥1000 per microliter \\[\u002FμL\\]) without granulocyte colony-stimulating factor support\n* Platelet count ≥ 50 × 109\u002FL (50,000\u002FμL) without transfusion\n* Hemoglobin ≥ 80 grams per liter (g\u002FL) (8 grams per deciliter \\[g\u002FdL\\]) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 × upper limit of normal (ULN)\n* Serum bilirubin ≤ 3 × ULN\n* Creatinine clearance ≥ 50 milliliters per minute (mL\u002Fmin) (calculated using the Cockcroft-gault formula)\n* Serum albumin ≥ 20 g\u002FL (2.0 g\u002FdL) without transfusion in the prior 3 months\n* International normalized ratio (INR) ≤2.3\n\nGeneral Exclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies\n* Treatment with investigational therapy within 28 days prior to initiation of study treatment\n* Treatment with locoregional therapy to liver within 28 days prior to initiation of study treatment, or non-recovery from side effects of any such procedure\n* Treatment with systemic immunostimulatory agents\n* Treatment with systemic immunosuppressive medication\n* Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment\n* Inadequately controlled hypertension\n* Active or history of autoimmune disease or immune deficiency\n* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan\n* Participants who have a known concurrent malignancy that is progressing or requires active treatment, who have not completely recovered from treatment, or who have a significant malignancy history that, in the opinion of the investigator, should preclude participation\n* Participants on preventative hormonal therapies (i.e., tamoxifen and other hormonal inhibitors) are not excluded\n* Known fibrolamellar HCC, sarcomatoid HCC, other rare HCC variant, or mixed cholangiocarcinoma and HCC\n* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases\n* Prior allogeneic stem cell or solid organ transplantation\n* Actively listed for liver transplantation\n* Co-infection with hepatitis B virus (HBV) and hepatitis C virus (HCV)\n* Untreated or incompletely treated esophageal and\u002For gastric varices with bleeding or that are at high risk for bleeding\n* A prior bleeding event due to esophageal and\u002For gastric varices within 6 months prior to initiation of study treatment\n* Grade ≥3 hemorrhage or bleeding event within 6 months prior to initiation of study treatment\n* Hepatic encephalopathy is allowed if no active symptoms or stable within 3 months of study treatment\n* History, planned, or recommended placement of transjugular intrahepatic portosystemic shunt (TIPS) is excluded from Cohort A only. TIPS is acceptable in Cohort B\n* Diagnostic paracentesis is allowed. Therapeutic paracentesis: one large volume paracentesis prior to enrollment with diuretic controlled ascites is allowed.\n* Participants with ascites controlled on diuretics are allowed\n* History of spontaneous bacterial peritonitis within last 12 months","ALL","18 Years",{"count":604,"type":605},30,"ESTIMATED","INTERVENTIONAL",[608],"PHASE2","The purpose of this study is to assess the safety of atezolizumab and bevacizumab, or atezolizumab alone, as first-line treatment in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC) with Child-pugh B7 or B8 cirrhosis.",[611],"Hepatocellular Carcinoma",[613,614,615,616,611,22,28,617,618,599,619,620,621,622,623,624,625,626,627,628,629,630],"Cirrhosis","Liver Cancer","Liver Tumor","Child-pugh B","Immune Checkpoint Inhibitor","Digestive System Neoplasms","ML44719","Liver Disease","Genentech","Immunotherapy","CPB","CPB 7","CPB 8","Tecentriq","Avastin","HCC","Cirrhotic Liver","Fatty Liver","2026-06-28",{"date":633,"type":634},"2026-06-30","ACTUAL",{"date":636,"type":634},"2024-07-15",{"date":638,"type":605},"2027-12-30",{"name":5,"class":6},62]