NCT07081633Active, not recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 114 (actual)
- First submitted
- 23 Jun 2025
- Start date
- 5 Aug 2025
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- AstraZeneca
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07081633
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 114
- From 5 Aug 2025 to the primary completion date, 30 Nov 2026
- 16 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) Grade ≥2 from previous anticancer therapy.
- Active or prior documented GI bleeding.
Other illness
- History of hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy.
- Patients with main portal vein thrombosis.
- 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
Other
- Clinically meaningful ascites.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.