Durvalumab and Tremelimumab With Lenvatinib as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma
NCT ID: NCT07081633
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
114 participants
INTERVENTIONAL
2025-08-05
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm
Durvalumab and Tremelimumab with Lenvatinib
Durvalumab
Durvalumab IV (intravenous infusion)
Tremelimumab
Tremelimumab IV (intravenous infusion)
Lenvatinib
Lenvatinib Oral
Interventions
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Durvalumab
Durvalumab IV (intravenous infusion)
Tremelimumab
Tremelimumab IV (intravenous infusion)
Lenvatinib
Lenvatinib Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Chengdu, , China
Research Site
Chongqing, , China
Research Site
Guangzhou, , China
Research Site
Guangzhou, , China
Research Site
Guangzhou, , China
Research Site
Guangzhou, , China
Research Site
Hangzhou, , China
Research Site
Hefei, , China
Research Site
Jinan, , China
Research Site
Nanjing, , China
Research Site
Nanjing, , China
Research Site
Ningbo, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Taiyuan, , China
Research Site
Tianjin, , China
Research Site
Wenzhou, , China
Research Site
Wuhan, , China
Research Site
Xiamen, , China
Research Site
Zhengzhou, , China
Research Site
New Territories, , Hong Kong
Countries
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Central Contacts
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AstraZeneca Clinical Study Information Center
Role: CONTACT
Phone: 1-877-240-9479
Email: [email protected]
Other Identifiers
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D419CL00025
Identifier Type: -
Identifier Source: org_study_id