NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

A Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab

NCT04770896

Active Not RecruitingPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Unresectable Hepatocellular Carcinoma

Interventions: Atezolizumab, Lenvatinib, Sorafenib

Countries: Austria, Belgium, Brazil, Bulgaria, Canada, China, Costa Rica, Croatia

This is a Phase III, open-label, multicenter, randomized, two-arm study designed to evaluate the efficacy and safety of atezolizumab plus either lenvatinib or sorafenib versus lenvatinib or sorafenib alone in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have progressed on prior systemic treatment with atezolizumab plus bevacizumab combination.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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.
* 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 (SD), partial response (PR), or complete response (CR).
* At least one measurable (per RECIST v1.1) target lesion that has not been previously treated with local therapy or, if the target lesion is within the field of previous local therapy, has subsequently progressed in accordance with RECIST v1.1.
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 within 7 days prior to randomization
* Child-Pugh class A within 7 days prior to randomization
* Adequate hematologic and end-organ function

Exclusion Criteria:

* Symptomatic, untreated, or actively progressing central nervous system (CNS) 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
* History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death

Locations (123)

Innsbruck, Austria
Salzburg, Austria
Sankt Pölten, Austria
Vienna, Austria
Brasschaat, Belgium
Brussels, Belgium
Leuven, Belgium
Roeselare, Belgium
Belo Horizonte, Minas Gerais, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Florianópolis, Santa Catarina, Brazil
Rio de Janeiro, Brazil
São Paulo, Brazil
Panagyurishte, Bulgaria
Plovdiv, Bulgaria
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Hamilton, Ontario, Canada
Toronto, Ontario, Canada
Changsha, China
Fuzhou, China
Guangzhou, China
Guangzhou, China
Hefei, China
Nanjing, China
Shanghai, China
Shanghai, China
Shenyang, China
Tianjin, China
+ 93 more on CT.gov