A Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma
NCT06371157 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 469
Last updated 2025-03-12
Summary
A study to evaluate cadonilimab (AK104) + lenvatinib in combination with transarterial chemoembolization (TACE) versus TACE in participants with incurable/non-metastatic hepatocellular carcinoma
Conditions
Interventions
- DRUG
-
AK104
intravenous
- DRUG
-
oral
- PROCEDURE
-
TACE
TACE (chemo and embolic agent injection into the hepatic artery)
- OTHER
-
Placebo for AK104
intravenous
- OTHER
-
Placebo for Lenvatinib
oral
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Guoliang Shao, MD · Zhejiang Cancer Hospital
-
Gaojun Teng, MD · Zhongda Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-08-02
- Primary Completion
- 2025-10-25
- Completion
- 2026-05-23
Countries
- China
Study Locations
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