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

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three drugs — durvalumab (an immunotherapy), tremelimumab (another immune-boosting drug), and lenvatinib (a targeted drug that slows cancer growth) — as a first-line treatment for people with liver cancer (hepatocellular carcinoma or HCC) that cannot be surgically removed. **You may be eligible if...** - You have been diagnosed with liver cancer confirmed by tissue biopsy or imaging - You have not received prior systemic (body-wide) treatment for unresectable HCC - Your liver function is relatively preserved (Child-Pugh class A, which means compensated liver disease) - You are in good general health (ECOG 0–1) and have at least one measurable tumor **You may NOT be eligible if...** - You have significant unresolved side effects from prior cancer treatment - You have had a recent episode of mental confusion related to liver disease (hepatic encephalopathy), clinically significant fluid buildup in the abdomen (ascites), or a blood clot blocking the main portal vein - You have active or recent gastrointestinal bleeding - You have uncontrolled high blood pressure or are co-infected with both hepatitis B and C Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDurvalumab

Durvalumab IV (intravenous infusion)

DRUGTremelimumab

Tremelimumab IV (intravenous infusion)

COMBINATION_PRODUCTLenvatinib

Lenvatinib Oral


Locations(24)

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

View Full Details on ClinicalTrials.gov

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NCT07081633


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