2023-503229-21-00招募中3 期
A PHASE III, OPEN-LABEL, RANDOMIZED STUDY OF ATEZOLIZUMAB WITH LENVATINIB OR SORAFENIB VERSUS SORAFENIB OR LENVATINIB ALONE IN HEPATOCELLULAR CARCINOMA PREVIOUSLY TREATED WITH ATEZOLIZUMAB AND BEVACIZUMAB
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 270
- 试验地点
- 62
研究概览
简要总结
-To evaluate the efficacy of atezolizumab plus lenvatinib or sorafenib compared with lenvatinib or sorafenib alone, on basis of the overall survival (OS)
研究设计
- 分配方式
- Randomized
- 主要目的
- A Study Of Atezolizumab With Lenvatinib Or Sorafenib In Hepatocellular Carcinoma
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/ cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic patients
- •Patients without cirrhosis require histological confirmation of diagnosis. HCC must be unamenable to curative surgical and/or locoregional therapies, or have progressed after surgical and /or locoregional therapies
- •Eastern Cooperative Oncology Group Performance Status of 0 or 1 within 7 days prior to randomization
- •Child-Pugh class A within 7 days prior to randomization
- •Life expectancy of at least 12 weeks
- •Patients with active hepatitis B virus (HBV) must have HBV deoxyribonucleic acid (DNA) < 500 international units per milliliter (IU/mL) obtained within 28 days prior to initiation of study treatment and received anti-HBV treatment (per local standard of care; e.g., entecavir) for a minimum of 14 days prior to study entry and willingness to continue treatment for the length of the study
排除标准
- •Symptomatic, untreated, or actively progressing central nervous system metastases
- •History of leptomeningeal disease and hepatic encephalopathy
- •History of malignancy other than HCC within 5 years prior to screening
- •Significant cardiovascular disease within 3 months prior to initiation of study treatment
- •Known allergy or hypersensitivity to any of the investigational medicinal product (IMPs) or constituents of the products
- •Treatment with an investigational therapy within 28 days prior to initiation of study treatment
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (62)
Loading locations...
相似试验
进行中（未招募）
3 期
A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy (Astefania)2023-503568-18-00F. Hoffmann-La Roche AG377
招募中
2 期
A randomized, 2-arm non-comparative phase II study on the efficacy of atezolizumab and Roche bevacizumab (Atezo/Bev) followed by on-demand selective TACE (sdTACE) upon detection of disease progression or of initial synchronous treatment with TACE and Atezo/Bev on objective response rate in the treatment of unresectable hepatocellular carcinoma patients (DEMAND)2024-512682-14-00Klinikum der Universitaet Muenchen AöR100
招募中
3 期
Study of Cabozantinib in Combination With Atezolizumab compared to Second Novel Hormonal Therapy (NHT) in Subjects with Metastatic Castration-Resistant Prostate Cancer2024-516481-11-00Exelixis Inc.203
招募中
2 期
A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination with Atezolizumab versus Standard of Care as First-Line Treatment in Participants with Previously Untreated Extensive Stage Small Cell Lung CancerSmall Cell Lung Cancer2024-517490-24-00AbbVie Deutschland GmbH & Co. KG60
招募中
3 期
PHASE III RANDOMIZED STUDY OF FOLFOXIRI PLUS BEVACIZUMAB AND ATEZOLIZUMAB VERSUS FOLFOXIRI PLUS BEVACIZUMAB AS FIRST-LINE TREATMENT OF UNRESECTABLE pMMR AND IMMUNOSCORE IC-HIGH METASTATIC COLORECTAL CANCER PATIENTS. The AtezoTRIBE2 Study2023-506632-32-00Gruppo Oncologico Del Nord Ovest238