A Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients with Previously Treated Hepatocellular Unresectable Carcinoma

BeiGene Ltd., c/o BeiGene USA, Inc.0 个研究点目标入组 249 人开始时间: 2018年1月26日最近更新: 2023年10月3日

适应症

试验速览

暂无简介。

•1. Histologically confirmed HCC
•2. Barcelona Clinic Liver Cancer (BCLC) Stage B or C disease not amenable to locoregional therapy or relapsed after locoregional therapy, and not amenable to a curative treatment approach
•3. Has received at least 1 line of systemic therapy for unresectable HCC Measurable disease
•4. Child-Pugh score A
•5. Easter Cooperative Oncology Group (ECOG) Performance Status = 1
•6. 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 125
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 103

•1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology
•2. Prior therapies targeting PD-1 or PD-L1
•3. Has known brain or leptomeningeal metastasis
•4. Tumor thrombus involving main trunk of portal vein or inferior vena cava
•5. Loco-regional therapy to the liver within 4 weeks before enrollment
•6. Medical history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung diseases, etc
•7. Has received:
•a. Within 28 days or 5 half-lives (whichever is shorter) of the first study drug administration: any chemotherapy, immunotherapy (eg, interleukin, interferon, thymoxin) or any investigational therapies
•b. Within 14 days of the first study drug administration: sorafenib, regorafenib, or any Chinese herbal medicine or Chinese patent medicines used to control cancer
•8. Active autoimmune diseases or history of autoimmune diseases that may relapse.
•9. 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 study drug administration

发起方

BeiGene Ltd., c/o BeiGene USA, Inc.