A Phase III, Open-Label, Randomized Study Of Atezolizumab With Lenvatinib Or Sorafenib Versus Lenvatinib Or Sorafenib Alone In Hepatocellular Carcinoma Previously Treated With Atezolizumab And Bevacizumab.

F HoffmannLa Roche Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年7月22日

试验速览

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•Locally advanced or metastatic and or unresectable HCC with diagnosis confirmed by histology or cytology or clinically by American Association for the Study of Liver Diseases criteria in cirrhotic patients.
•Disease progression following prior atezolizumab plus bevacizumab combination treatment for HCC, for at least 4 consecutive treatment cycles, and 2 subsequent tumor assessments. It is required that at least 1 tumor assessment shows either stable disease, partial response, or complete response.
•Child-Pugh class A within 7 days prior to randomization.
•ECOG Performance Status of 0 or 1 within 7 days prior to randomization.
•Life expectancy of at least 12 weeks.
•Resolution of any acute, clinically significant treatment-related toxicity from prior therapy to Grade less than equal to 1 prior to study entry, with the exception of alopecia.

•Symptomatic, untreated, or actively progressing central nervous system metastases.
•History of leptomeningeal disease.
•History of hepatic encephalopathy, preceding 6 months, unresponsive to therapy within 3 days.
•Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
•Patients receiving any TKI or PD-1/PD-L1 antibody or such combination in a previous treatment line against HCC (except atezolizumab plus bevacizumab combination).
•Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte?associated protein 4 (CTLA-4), anti-PD-1, and anti-PD-L1 (other than atezolizumab) therapeutic antibodies.
•Patients who discontinued atezolizumab in a previous treatment line against HCC primarily for toxicity or intolerability are not eligible for the study.
•Patients on a liver transplantation list.
•Prior allogeneic stem cell or solid organ transplantation.

发起方

F HoffmannLa Roche Ltd