A Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Hepatocellular Carcinoma

In brief

A study to evaluate cadonilimab (AK104) + lenvatinib in combination with transarterial chemoembolization (TACE) versus TACE in participants with incurable/non-metastatic hepatocellular carcinoma

Key facts

Study ID

NCT06371157

Run by

Akeso

People needed

469

Starts

2024-08-02

Expected to finish

2026-05-23

Last updated by the study team

2025-03-12

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has a diagnosis of HCC confirmed by histology/cytology，or meet the clinical diagnostic criteria of the American Association for the Study of Liver Diseases (AASLD)
• No evidence of metastasis
• Not amenable to curative surgery or transplantation or curative ablation but amenable to TACE
• Child Pugh score class A
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
• Measurable disease by RECIST 1.1
• Adequate organ function

You may not qualify if…

• History of liver transplantation
• History of hepatic encephalopathy
• Uncontrolled arterial hypertension
• Deep venous thrombosis within 3 months before first treatment
• Bleeding events within the last 6 months
• Co-infection with HBV and HCV

Where it is running

• Henan Cancer Hospital — Zhengzhou, Henan, China (enrolling)
• Hunan Cancer Hospital — Changsha, Hunan, China (enrolling)
• Zhongda Hospital Southeast University — Nanjing, Jiangsu, China (enrolling)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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