Actively Recruiting
A Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet for Advanced HCC.
Led by Akeso · Updated on 2026-03-16
100
Participants Needed
1
Research Sites
128 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
An Open-label, Multicenter, Phase II Clinical Study of AK104/AK112 in Combination with TT-00420 Tablet in Patients with Advanced Hepatocellular Carcinoma(HCC).
CONDITIONS
Official 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 18 to 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
- No prior systemic anti-cancer treatment for hepatocellular carcinoma for cohorts A and B
- At least one measurable lesion according to RECIST v1.1 criteria
- Child-Pugh liver function score of 7 or less
- ECOG performance status of 0 or 1
- Clinically controllable hepatitis B virus (HBV) or hepatitis C virus (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
- Diagnosis of another malignancy within the past 3 years
- History of hepatic encephalopathy
- Clinically significant pericardial effusion; symptomatic pleural effusion requiring drainage; 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
- Imaging shows extrahepatic metastasis invading major blood vessels or high bleeding risk
- Liver tumor volume over 50% of total liver volume; portal vein or mesenteric vein tumor thrombus; inferior vena cava thrombus or heart involvement
- Receipt of topical liver cancer treatment, systemic anti-tumor drugs, or other clinical trial drugs within 4 weeks prior to first administration
- Unable to swallow or severe gastrointestinal disease/dysfunction; history of intestinal obstruction or perforation within 6 months
- 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 administration or systemic anti-infective treatment within 14 days
- Other high medical risk conditions or secondary tumor symptoms judged by researcher as unsuitable for participation
AI-Screening
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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.
CONTACT
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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