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 USA, INC.0 个研究点目标入组 640 人开始时间: 2021年1月21日最近更新: 2021年8月2日

研究概览

暂无简介。

•1. Histologically confirmed diagnosis of HCC
•2. Barcelona Clinic Liver Cancer (BCLC) Stage B or C disease not amenable to or progressing after loco-regional therapy and not amenable to a curative treatment approach
•3. No prior systemic therapy for HCC (with the exception of HCC patients enrolled in the safety run-in substudy [Japan only])
•4. Measurable disease
•5. Child-Pugh score A
•6. Easter Cooperative Oncology Group (ECOG) Performance Status = 1
•7. Adequate organ function
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 384
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 256

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

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