RecruitingPhase 3NCT05557838

Study of Durvalumab Plus Tremelimumab as First-line Treatment in Chinese Patients With Unresectable Hepatocellular Carinoma

An Open-label, Multi-center Phase IIIb Study of Durvalumab and Tremelimumab as First-Line Treatment in Patients With Unresectable Hepatocellular Carcinoma


Sponsor

AstraZeneca

Enrollment

210 participants

Start Date

Feb 22, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, open label, multi-center, interventional study to assess the safety and efficacy of Druvalumab plus Tremelimumab as first-line treatment in Chinese patients with unresectable hepatocellular carcinoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two immunotherapy drugs — durvalumab and tremelimumab — as a first-line treatment for Chinese patients with advanced liver cancer (hepatocellular carcinoma, or HCC) that cannot be surgically removed. **You may be eligible if:** - You have been diagnosed with liver cancer (HCC) confirmed by tissue biopsy or imaging - You have not previously received any systemic treatment for HCC - Your cancer is at an advanced stage (BCLC B not suitable for local treatment, or BCLC C) - Your liver function is reasonably preserved (Child-Pugh class A or B) - You have at least one measurable tumor **You may NOT be eligible if:** - You had a brain episode related to liver disease (hepatic encephalopathy) in the last 12 months - You have significant fluid buildup in your abdomen (clinically meaningful ascites) - You have a blood clot in your main portal vein from the tumor - You have had active bleeding from the gut (such as esophageal varices) in the last 6 months - You have both hepatitis B and hepatitis C, or both hepatitis B and hepatitis D 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)


Locations(32)

Research Site

Beijing, China

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Beijing, China

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Beijing, China

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Beijing, China

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Changsha, China

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Changsha, China

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Chengdu, China

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Fuzhou, China

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Guangzhou, China

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Guangzhou, China

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Guangzhou, China

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Guangzhou, China

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Hangzhou, China

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Harbin, China

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Jinan, China

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Nanjing, China

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Nanjing, China

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Nanjing, China

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Ningbo, China

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Shanghai, China

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Shanghai, China

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Shenyang, China

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Tianjin, China

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Tianjin, China

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Tianjin, China

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Wenzhou, China

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Wuhan, China

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Wuhan, China

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Xi'an, China

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Zhangjiagang, China

Research Site

Zhengzhou, China

Research Site

Zhengzhou, China

View Full Details on ClinicalTrials.gov

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NCT05557838


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