Actively Recruiting
A Study of AK112 in Patients With Advanced Hepatocellular Carcinoma (HCC)
Led by Akeso · Updated on 2026-03-04
280
Participants Needed
2
Research Sites
205 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
There're 2 parts in this interventional study: 1. The goal of phase Ib trial is to evaluate the safety and tolerability of AK112 in combination therapies for the purpose of observing the incidence of dose limit toxicity (DLT) as well as the confirmation of maximum tolerable dose (MTD) in the treatment of advanced hepatocellular carcinoma (HCC), so as to determine the recommended phase 2 dose (RP2D) in the second part of the trial. 2. The goal of phase II trial is to evaluate the safety and efficacy of AK112 in combination therapy or monotherapy in the treatment of HCC compared to the combination of Sintilimab and Bevacizumab biosimilar.
CONDITIONS
Official Title
A Study of AK112 in Patients With Advanced Hepatocellular Carcinoma (HCC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent.
- Life expectancy of at least 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- HCC confirmed by histology/cytology or by the American Society for the Study of Hepatology (AASLD) clinical diagnostic criteria in patients with cirrhosis.
- Phase Ib: Barcelona Clinical Liver Cancer (BCLC) stage B or C; failed standard treatment; no more than two lines of prior anti-tumor treatment.
- Phase II: BCLC stage C not suitable for curative or local treatment, or stage B not curable after such treatments; no prior systemic anti-tumor treatment for HCC.
- At least one untreatable measurable lesion or measurable lesion with clear progression after local treatment according to RECIST v1.1.
- Liver function Child Pugh Grade A.
- Adequate organ function.
- Agree to use effective contraception during and for 120 days after last dose if of reproductive potential.
- Able to comply with all study procedures and requirements.
You will not qualify if you...
- Histology/cytology showing fibrous layer hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or cholangiocarcinoma.
- Other malignant tumors within 5 years prior to enrollment except cured basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical or breast cancer in situ.
- Tumor volume greater than 50% of liver volume; portal vein cancer thrombus (Vp4); inferior vena cava cancer thrombus.
- Tumors invading important organs or blood vessels that increase bleeding risk.
- Central nervous system metastasis, spinal cord compression, or meningeal metastasis.
- Pleural effusion, pericardial effusion, or ascites with symptoms or requiring repeated drainage.
- Prior immunotherapy including immune checkpoint inhibitors or immune cell therapy.
- Local liver treatment within 4 weeks prior to first dose; palliative radiotherapy for non-liver patients within 2 weeks prior.
- History of non-infectious pneumonia requiring systemic glucocorticoids or current serious lung diseases.
- History of severe bleeding tendency or coagulation dysfunction.
- History of myocarditis, cardiomyopathy, or malignant arrhythmia.
- Arterial or venous thromboembolism, transient ischemic attacks, cerebrovascular accidents, hypertensive crises, or encephalopathy within 6 months prior to first dose.
- Pregnant or lactating females.
- Any condition or abnormality that may interfere with study results or full participation.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Actively Recruiting
2
Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital)
Jinan, Shandong, China
Actively Recruiting
Research Team
W
Wenting Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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