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

JRCT ID: jRCT2031210045

Registered date:21/04/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: 2L HCC
• Date of first enrollment: 16/07/2021
• Target sample size: 554
• Countries of recruitment: Austria,Japan,Belgium,Japan,Brazil,Japan,Bulgaria,Japan,Canada,Japan,Chile,Japan,China,Japan,Costa Rica,Japan,Croatia,Japan,Estonia,Japan,Finland,Japan,France,Japan,Germany,Japan,Greece,Japan,Israel,Japan,Italy,Japan,Korea,Japan,Malaysia,Japan,Philippines,Japan,Russian Federation,Japan,Slovenia,Japan,Spain,Japan,Switzerland,Japan,Taiwan,Japan,Thailand,Japan,Turkey,Japan,United Kingdom,Japan
• Study type: Interventional

Intervention(s)

Atezolizumab will be administered by intravenous (IV) infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Lenvatinib will be administered once daily by mouth each day of every 21-day study treatment cycle. Participants with a baseline body weight of < 60 kg will receive a daily dose of 8 mg. Participants with a baseline body weight of 60 kg or more will receive a daily dose of 12 mg.
Sorafenib will be administered at a dose of 800 mg per day, i.e. two tablets of 200 mg swallowed by mouth twice daily (equivalent to a total daily dose of 800 mg) each day of every 21-day study treatment cycle.

Outcome(s)

Primary Outcome

Efficacy
Obsrvation/Clinical examination

Secondary Outcome

Safety/Efficacy
Observation/Clinical examination, RECIST v1.1

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude criteria

-Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
-History of leptomeningeal disease
-History of hepatic encephalopathy, proceeding 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

Related Information

• Primary Sponsor: Natsumi Irahara,Ph.D.
• Secondary ID(s): NCT04770896