A Randomized, Open-label, Multicenter Phase 3 Study to Compare the Efficacy and Safety of BGB-A317 versus Sorafenib as First-Line Treatment in Patients with Unresectable Hepatocellular Carcinoma

BeiGene, Ltd. (ICCC:PAREXEL International Inc.)0 个研究点目标入组 96 人开始时间: 2019年1月9日最近更新: 2023年10月17日

研究概览

暂无简介。

•1.Has a histologically confirmed diagnosis of HCC
•2.Has either BCLC Stage C disease, or BCLC Stage B disease that is not amenable to or has progressed after loco-regional therapy, and is not amenable to a curative treatment approach
•3.Has received no prior systemic therapy for HCC
•4.Has >= 1 measurable lesion
•5.Has Child-Pugh A classification
•6.Has ECOG PS score <= 1
•7.Has adequate organ function

•1.Has known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology
•2.Has tumor thrombus involving main trunk of portal vein or inferior vena cava
•3.Has received within 28 days before randomization loco-regional therapy to the liver
•4.Has, at Screening, or has had within 6 months before randomization any clinical evidence of portal hypertension with bleeding esophageal or gastric varices
•5.Has, at Screening, or has had within 6 months before randomization, any bleeding or thrombotic disorder or any prescribed anticoagulant requiring therapeutic international normalized ratio monitoring
•6.Has, at Screening, any active immune deficiency or autoimmune disease and/or has a history of any immune deficiency or autoimmune disease that may relapse
•7.Has any condition that has required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before randomization
•8.Has any history of interstitial lung disease or non-infectious pneumonitis, unless induced by radiation therapy
•9.Has Screening ECGs with QT interval corrected for heart rate (QTc) (corrected by Fridericia ' s method) > 450 msec

发起方

BeiGene, Ltd. (ICCC:PAREXEL International Inc.)