Tremelimumab: Tremelimumab IV (intravenous infusion)
Lenvatinib: Lenvatinib Oral
Study summary
This is a Phase II, single-arm, multicentre study, assessing the efficacy and safety of durvalumab and tremelimumab with lenvatinib in participants with unresectable HCC.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Confirmed HCC based on histopathological findings from tumor tissues or radiologically findings.
* Must not have received prior systemic therapy for unresectable HCC.
* Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C.
* Child-Pugh Score class A.
* ECOG performance status of 0 or 1 at enrollment.
* At least 1 measurable lesion per RECSIT 1.1 guidelines
Exclusion Criteria:
* Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) Grade ≥2 from previous anticancer therapy.
* History of hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy.
* Clinically meaningful ascites.
* Patients with main portal vein thrombosis.
* Active or prior documented GI bleeding.
* Patient currently exhibits symptomatic or uncontrolled hypertension.
* Patients co-infected with HBV and HCV, or co-infected with HBV and hepatitis D virus (HDV)
* Uncontrolled intercurrent illness
Primary outcome measure(s)
Progression free survival (PFS) per RECIST 1.1 — From the date of first dose until the date of objective PD per RECIST 1.1 or death, whichever came first. It will be assessed when approximately 69 PFS events have occurred (60% maturity), approximately 8 months after the last patients dosed. Efficacy endpoint
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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