RecruitingPhase 3NCT06371157

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

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


Sponsor

Akeso

Enrollment

469 participants

Start Date

Aug 2, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatment approaches for people with liver cancer (hepatocellular carcinoma) that cannot be surgically removed or has not spread. One group receives a standard procedure called TACE (a targeted chemotherapy delivered directly to the liver) combined with two immunotherapy/anti-tumor drugs. The other group receives TACE alone. **You may be eligible if...** - You have confirmed liver cancer that cannot be cured by surgery, transplant, or ablation - Your cancer has not spread to other organs - Your liver function is relatively preserved (Child-Pugh class A) - Your overall health status is good (ECOG 0 or 1) **You may NOT be eligible if...** - You have had a liver transplant or hepatic encephalopathy (brain confusion from liver disease) - You have uncontrolled high blood pressure or a recent blood clot - You have had significant bleeding in the last 6 months - You have both hepatitis B and C at the same time Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAK104

intravenous

DRUGLenvatinib

oral

PROCEDURETACE

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

OTHERPlacebo for AK104

intravenous

OTHERPlacebo for Lenvatinib

oral


Locations(4)

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

View Full Details on ClinicalTrials.gov

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NCT06371157


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