Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT06371157

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

Led by Akeso · Updated on 2025-03-12

469

Participants Needed

4

Research Sites

94 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with hepatocellular carcinoma confirmed by histology, cytology, or clinical criteria from the American Association for the Study of Liver Diseases
  • No evidence of metastasis
  • Not suitable for curative surgery, transplantation, or ablation but can receive 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Henan Cancer Hospital

Zhengzhou, Henan, China, 450004

Actively Recruiting

2

Hunan Cancer Hospital

Changsha, Hunan, China, 410006

Actively Recruiting

3

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China, 210009

Actively Recruiting

4

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China, 310005

Actively Recruiting

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Research Team

T

Ting Liu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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