STRIDE (Durvalumab + Tremelimumab) With Lenvatinib vs STRIDE Alone in Unresectable Hepatocellular Carcinoma
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. * Must not have received prior systemic therapy for HCC. * Must not be eligible for locoregional therapy for unresectable HCC. For patients who progressed after locoregional therapy for HCC, locoregional therapy must have been completed ≥28 days prior to the baseline scan of the abdomen and pelvis for the current study. * Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C. * Child-Pugh Score class A or B7 based on low albumin (albumin 25-27 g/L) only. * Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * At least 1 measurable lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have