The purpose of this study is to compare the effects on participants' and liver cancer by adding a drug that is used on its own to treat this disease to a combination of two other drugs which is also used to treat liver cancer, compared to the two-drug combination alone.
Age ≥ 18 years.
Body weight > 30 kg.
Life expectancy of at least 12 weeks.
Confirmed HCC based on histopathological findings from tumour tissues or clinically by AASLD criteria in cirrhotic participants.
Participants with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other tumours curatively treated with no evidence of disease for ≥ 5 years.
Any concurrent chemotherapy, study drug, or biologic or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
Known fibrolamellar HCC, sarcomatoid HCC, infiltrative-type HCC or mixed cholangiocarcinoma and HCC.
Clinically meaningful ascites, defined as ascites requiring non-pharmacologic intervention
Parallel
STRIDE (durvalumab + tremelimumab)
DrugAs first treatment
Durvalumab
Drugmonotherapy every 4 weeks
Lenvatinib
DrugDaily
Progression-free Survival using RECIST 1.1
Overall Survival
Number and Severity of Adverse Events using CTCAE
Objective Response Rate using RECIST 1.1
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Canadian Cancer Trials Group
Lead sponsor
AstraZeneca
Collaborator
National Cancer Institute, Naples
Collaborator
