RecruitingPhase 3NCT05489289

A Phase III Study of AK104 as Adjuvant Therapy in HCC With High Risk of Recurrence After Curative Resection

A Randomized, Double-blind, Phase III Clinical Study on the Efficacy and Safety of AK104 Versus Placebo as Adjuvant Therapy for Hepatocellular Carcinoma With High Risk of Recurrence After Curative Resection


Sponsor

Akeso

Enrollment

570 participants

Start Date

Jan 5, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The efficacy and safety of AK104 as adjuvant therapy in hepatocellular carcinoma of high recurrence risk after curative resection.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called AK104 — an immunotherapy that activates the immune system to fight cancer — as a treatment after surgery in patients with liver cancer (hepatocellular carcinoma, HCC) who are at high risk of the cancer coming back. **You may be eligible if...** - You have been diagnosed with liver cancer (HCC) confirmed by tissue biopsy - You had a complete surgical removal of your cancer with no remaining tumor - You have at least one risk factor for cancer recurrence after surgery - Your liver function is good (Child-Pugh grade A) and you feel well (ECOG score 0) - Your underlying liver disease (such as hepatitis) is under control **You may NOT be eligible if...** - You have a rare type of liver cancer (such as fibrolamellar or sarcoma-like HCC, or cholangiocarcinoma) - You had cancer treatments other than surgery before enrollment - You have poor liver function, active infection, bleeding risks, or uncontrolled high blood pressure or heart problems - You have active autoimmune disease or a history of organ transplant - You are pregnant 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

BIOLOGICALAK104

Subjects will receive AK104 until disease progression or for a maximum of 16 cycles

BIOLOGICALplacebo

Subjects will receive placebo until disease progression or for a maximum of 16 cycles


Locations(1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

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NCT05489289


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