RecruitingPhase 2NCT07081633
Durvalumab and Tremelimumab With Lenvatinib as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma
An Open-label, Multi-center Phase II Study of Durvalumab and Tremelimumab With Lenvatinib as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma
Sponsor
AstraZeneca
Enrollment
114 participants
Start Date
Aug 5, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria6
- 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 Criteria8
- 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
Interventions
DRUGDurvalumab
Durvalumab IV (intravenous infusion)
DRUGTremelimumab
Tremelimumab IV (intravenous infusion)
COMBINATION_PRODUCTLenvatinib
Lenvatinib Oral
Locations(24)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07081633
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