Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06371157

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Henan Cancer Hospital, Zhengzhou, Henan, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

AK104

Drug

intravenous

Lenvatinib

Drug

oral

TACE

Procedure

TACE (chemo and embolic agent injection into the hepatic artery)

Placebo for AK104

Other

intravenous

Placebo for Lenvatinib

Other

oral

Primary outcomes

  1. Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

    Time frame: Up to approximately 2 years

    PFS is defined as the time from randomization to the first documented progressive disease or death due to any cause, whichever occurs first. Responses are according to RECIST 1.1 as assessed by blinded independent central review (BICR).

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to approximately 2 years

    OS is defined as the time from randomization to death due to any cause.

  2. PFS per RECIST 1.1

    Time frame: Up to approximately 2 years

    Assessed by investigators

  3. Objective Response Rate (ORR) per RECIST 1.1 and Modified Response Evaluation Criteria in Solid Tumors (mRECIST)

    Time frame: Up to approximately 2 years

    Assessed by BICR and investigators

  4. Duration of Response (DOR) per RECIST 1.1 and mRECIST

    Time frame: Up to approximately 2 years

    Assessed by BICR and investigators

  5. Disease Control Rate (DCR) per RECIST 1.1 and mRECIST

    Time frame: Up to approximately 2 years

    Assessed by BICR and investigators

  6. Time to Response (TTR) per RECIST 1.1 and mRECIST

    Time frame: Up to approximately 2 years

    Assessed by BICR and investigators

Study contacts

Contact information is provided by the study sponsor or research team.

Ting Liu

CONTACT

[email protected]

+86 (0760) 8987 3999

Sponsors and collaborators

Lead sponsor

Akeso

Industry

Registry information

Official study title

A Phase III, Randomized, Double-blinded, Multicenter Study of Cadonilimab (AK104) + Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 17, 2024
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.