Actively Recruiting
An Open-label, Multicenter, Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet in Patients With Advanced Hepatocellular Carcinoma
Led by Akeso · Updated on 2026-03-16
100
Participants Needed
1
Research Sites
33 weeks
Total Duration
On this page
Sponsors
A
Akeso
Lead Sponsor
T
TransThera Sciences (Nanjing), Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of AK104 or AK112 with TT-00420 tablet in patients with advanced hepatocellular carcinoma (HCC), a type of liver cancer. This open-label, multicenter Phase II clinical trial aims to assess these treatments' effects in adults aged 18 to 75 years who have confirmed advanced HCC. The study focuses on measuring the objective response rate and other outcomes over up to two years. Participants receive one of several treatment regimens: AK104 given intravenously at 10 mg/kg every three weeks plus TT-00420 orally at 10 mg daily; AK112 given intravenously at 20 mg/kg every three weeks plus TT-00420 at the same oral dose; or TT-00420 alone. The study includes safety lead-in phases and expansion cohorts with different participant groups receiving these combinations or monotherapy. During the study, participants undergo regular assessments including scans and clinical evaluations to monitor tumor response, disease progression, survival, and safety. Researchers track outcomes such as progression-free survival, disease control rate, duration and time to response, time to progression, and overall survival for up to two years. The total participation duration varies with study phase and treatment group.
CONDITIONS
Brief Title
A Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet for Advanced HCC.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Histologically or cytologically confirmed hepatocellular carcinoma or meets clinical diagnostic criteria
- Barcelona Clinic Liver Cancer (BCLC) stage C, or stage B unsuitable for curative topical treatment
- For cohorts A and B: no prior systemic anti-cancer treatment for hepatocellular carcinoma
- At least one measurable lesion by RECIST v1.1 criteria
- Child-Pugh liver function score of 7 or less
- ECOG performance status of 0 or 1
- Clinically controllable HBV or HCV infection
- Adequate organ and bone marrow function
You will not qualify if you...
- Previous diagnosis of fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, or similar
- Diagnosed with another malignancy within the past 3 years
- History of hepatic encephalopathy
- Clinically significant pericardial effusion or symptomatic pleural effusion requiring drainage or moderate to severe ascites uncontrolled by diuretics
- Concurrent infection with both HBV and HCV
- Presence of central nervous system or meningeal metastases
- Esophageal or gastric variceal bleeding within 6 months or high bleeding risk from vascular invasion
- Liver tumor volume over 50% of total liver volume or tumor thrombus in major vessels or heart involvement
- Received topical liver cancer treatment, systemic anti-tumor drugs, or other clinical trial drugs within 4 weeks before first dose
- Unable to swallow or has severe gastrointestinal disease or recent intestinal obstruction/perforation
- Uncontrolled hypertension, symptomatic heart failure, arrhythmia, myocarditis, cardiomyopathy, or history of malignant arrhythmias
- Severe bleeding tendencies or coagulation disorders
- Active pulmonary tuberculosis, active syphilis, or history of HIV infection
- Severe infection within 4 weeks prior to first dose or recent systemic anti-infective treatment
- Other high medical risk conditions or secondary tumor symptoms making participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive study drugs including AK104 or AK112 intravenously every 3 weeks and TT-00420 tablets taken orally daily as part of the treatment regimen for advanced hepatocellular carcinoma.
Visits every 3 weeks for drug administration and monitoring
Trial Site Locations
Total: 1 location
1
Union Hospital Tongji Medical College Huazhong University of Science And Technology
Wuhan, China, China, 430000
Actively Recruiting
Research Team
T
Ting Liu, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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