A Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma
NCT ID: NCT06371157
Last Updated: 2025-03-12
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
469 participants
INTERVENTIONAL
2024-08-02
2026-05-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm A
AK104+ Lenvatinib in Combination With Transarterial Chemoembolization (TACE)
AK104
intravenous
Lenvatinib
oral
TACE
TACE (chemo and embolic agent injection into the hepatic artery)
Arm B
Placebo for AK104 + Placebo for Lenvatinib in Combination With TACE
TACE
TACE (chemo and embolic agent injection into the hepatic artery)
Placebo for AK104
intravenous
Placebo for Lenvatinib
oral
Arm C
AK104 + Placebo for Lenvatinib in Combination With TACE
AK104
intravenous
TACE
TACE (chemo and embolic agent injection into the hepatic artery)
Placebo for Lenvatinib
oral
Interventions
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AK104
intravenous
Lenvatinib
oral
TACE
TACE (chemo and embolic agent injection into the hepatic artery)
Placebo for AK104
intravenous
Placebo for Lenvatinib
oral
Eligibility Criteria
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Inclusion Criteria
2. No evidence of metastasis
3. Not amenable to curative surgery or transplantation or curative ablation but amenable to TACE
4. Child Pugh score class A
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
6. Measurable disease by RECIST 1.1
7. Adequate organ function
Exclusion Criteria
2. History of hepatic encephalopathy
3. Uncontrolled arterial hypertension
4. Deep venous thrombosis within 3 months before first treatment
5. Bleeding events within the last 6 months
6. Co-infection with HBV and HCV
18 Years
75 Years
ALL
No
Sponsors
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Akeso
INDUSTRY
Responsible Party
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Principal Investigators
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Guoliang Shao, MD
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Cancer Hospital
Gaojun Teng, MD
Role: PRINCIPAL_INVESTIGATOR
Zhongda Hospital
Locations
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Henan Cancer Hospital
Zhengzhou, Henan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Hailiang Li
Role: primary
Shanzhi Gu
Role: primary
Gaojun Teng
Role: primary
Guoliang Shao
Role: primary
Other Identifiers
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AK104-308
Identifier Type: -
Identifier Source: org_study_id
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