RecruitingPhase 2NCT07052253

A Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet for Advanced HCC.

An Open-label, Multicenter, Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet in Patients With Advanced Hepatocellular Carcinoma.


Sponsor

Akeso

Enrollment

100 participants

Start Date

Jul 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

An Open-label, Multicenter, Phase II Clinical Study of AK104/AK112 in Combination with TT-00420 Tablet in Patients with Advanced Hepatocellular Carcinoma(HCC).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This Phase II trial tests two combinations of immunotherapy drugs (AK104 or AK112) with a targeted drug (TT-00420) in people with advanced liver cancer (hepatocellular carcinoma) who have not previously received systemic treatment. **You may be eligible if:** - You are between 18 and 75 years old - Your liver cancer has been confirmed by biopsy or meets diagnostic criteria - Your disease is at an advanced stage (BCLC stage C) or stage B unsuitable for local curative treatment - You have not previously received systemic treatment for liver cancer - You have adequate liver function, organ function, and overall health status (ECOG 0 or 1) - Your hepatitis B or C infection is clinically controlled **You may NOT be eligible if:** - You have a rare subtype of liver cancer (e.g., fibrolamellar, sarcomatoid, or cholangiocarcinoma) - You have had another cancer in the past 3 years - You have a history of liver-related brain confusion (hepatic encephalopathy) - You have significant fluid around the heart, lungs, or abdomen - You have active tuberculosis, HIV, or syphilis - You have had esophageal or stomach variceal bleeding in the past 6 months - Your liver tumor takes up more than 50% of your liver 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

DRUGTT-00420 (tinengotinib)

oral

DRUGAK104

intravenous

DRUGAK112

intravenous


Locations(1)

Union Hospital Tongji Medical College Huazhong University of Science And Technology

Wuhan, China, China

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NCT07052253


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