Actively Recruiting
A Study of AK112, a PD-1/ VEGF Bispecific Antibody, for Resectable Hepatocellular Carcinoma With High Recurrence Risk
Led by The First Affiliated Hospital of Zhengzhou University · Updated on 2025-04-16
30
Participants Needed
1
Research Sites
159 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single-arm, open-label study. To assess the efficacy and safety of AK112 therapy in patients with resectable hepatocellular carcinoma at high risk of recurrence. The primary endpoint is the 12-month RFS rate of resectable hepatocellular carcinoma.
CONDITIONS
Official Title
A Study of AK112, a PD-1/ VEGF Bispecific Antibody, for Resectable Hepatocellular Carcinoma With High Recurrence Risk
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any trial procedures
- Male or female aged 18 to 75 years
- ECOG performance status score of 0 or 1
- Confirmed hepatocellular carcinoma by pathology or clinical diagnosis
- No prior treatment for HCC before surgery
- No lymph node invasion or distant metastasis on imaging
- Suitable for radical surgery as determined by investigator
- At least one high-risk factor for HCC recurrence after surgery such as large tumor size, vascular invasion, multiple nodules, or elevated AFP
- Child-Pugh score of A or B7
- Expected survival longer than 3 months
- At least one measurable lesion per RECIST 1.1 criteria
- Normal or asymptomatic thyroid hormone levels
- Adequate organ and bone marrow function within 7 days before randomization
- Negative pregnancy test for women of childbearing potential before first dose
- Use of effective contraception during treatment and up to 120 days after last dose
You will not qualify if you...
- Diagnosis of fibrolamellar or sarcomatoid HCC, cholangiocarcinoma, or similar
- Other cancers within 5 years except certain skin, bladder, cervical, or breast cancers
- History of hepatic encephalopathy or liver transplant
- Cancer thrombus in major veins
- Active hepatitis B or C with high viral load unless on antiviral therapy
- Symptomatic pleural effusion, ascites, or pericardial effusion needing drainage
- Recent variceal bleeding or significant varices
- History of serious bleeding or coagulation disorders
- Recent arterial or venous thromboembolism or certain stable thromboses
- History of serious heart conditions or unstable angina
- Severe ulcers, unhealed wounds, GI perforation or bleeding within 6 months
- Recent serious thromboembolic or hypertensive events
- Active or past autoimmune diseases requiring systemic treatment
- Immunodeficiency or long-term immunosuppressant use
- Known active tuberculosis or syphilis
- Severe infections recently or active infections requiring systemic treatment
- Previous systemic chemotherapy or bevacizumab treatment
- Prior immunotherapy or local liver therapies
- Use of systemic anti-tumor traditional Chinese medicine within 2 weeks
- Live vaccine within 30 days before first dose
- Allergy to study drugs or severe hypersensitivity to monoclonal antibodies
- Psychiatric disease, drug abuse, alcoholism, or substance addiction
- Pregnant or breastfeeding women
- Any condition that may interfere with the study or increase risk as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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