Study of Durvalumab Plus Tremelimumab as First-line Treatment in Chinese Patients With Unresectable Hepatocellular Carinoma
NCT ID: NCT05557838
Last Updated: 2025-02-07
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
PHASE3
210 participants
INTERVENTIONAL
2023-02-22
2025-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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cohort 1
durvalumab in combination with tremelimumab
Durvalumab
Durvalumab IV (intravenous infusion)
Tremelimumab
Tremelimumab IV (intravenous infusion)
cohort 2
durvalumab in combination with tremelimumab
Durvalumab
Durvalumab IV (intravenous infusion)
Tremelimumab
Tremelimumab IV (intravenous infusion)
Interventions
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Durvalumab
Durvalumab IV (intravenous infusion)
Tremelimumab
Tremelimumab IV (intravenous infusion)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No prior systemic therapy for HCC
* Barcelona Clinic Liver Cancer (BCLC) stage B (not eligible for locoregional therapy) or stage C
* Child-Pugh Score class A or B
* ECOG performance status (PS) of 0-2 at enrollment (Child-Pugh Score class A and ECOG PS of 0-1 will be enrolled in cohort 1 and Child-Pugh Score class B or ECOG PS of 2 will be enrolled in cohort 2)
* At least 1 measurable lesion per RECSIT 1.1 guidelines
Exclusion Criteria
* Clinically meaningful ascites
* Main portal vein tumor thrombosis
* Active or prior documented GI bleeding (eg, esophageal varices or ulcer bleeding) within 6 months
* HBV and HVC co-infection, or HBV and Hep D co-infection
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
Beijing, , China
Research Site
Changsha, , China
Research Site
Changsha, , China
Research Site
Chengdu, , China
Research Site
Fuzhou, , China
Research Site
Guangzhou, , China
Research Site
Guangzhou, , China
Research Site
Guangzhou, , China
Research Site
Guangzhou, , China
Research Site
Hangzhou, , China
Research Site
Harbin, , China
Research Site
Jinan, , China
Research Site
Nanjing, , China
Research Site
Nanjing, , China
Research Site
Nanjing, , China
Research Site
Ningbo, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Shenyang, , China
Research Site
Tianjin, , China
Research Site
Tianjin, , China
Research Site
Tianjin, , China
Research Site
Wenzhou, , China
Research Site
Wuhan, , China
Research Site
Wuhan, , China
Research Site
Xi'an, , China
Research Site
Zhangjiagang, , China
Research Site
Zhengzhou, , China
Research Site
Zhengzhou, , China
Countries
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Central Contacts
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Other Identifiers
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D419CR00026
Identifier Type: -
Identifier Source: org_study_id
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