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A Single-Arm, Multicenter, Exploratory Clinical Study on the Efficacy and Safety of AK112 in Perioperative Treatment of 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
82 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating AK112 therapy in patients with resectable hepatocellular carcinoma (HCC) who have a high risk of cancer recurrence. This single-arm, open-label Phase 4 study aims to assess the effectiveness and safety of AK112, focusing on the 12-month recurrence-free survival rate after surgery. The study is sponsored by The First Affiliated Hospital of Zhengzhou University and involves patients aged 18 to 75 years with confirmed HCC suitable for surgery. Participants receive AK112 at a dose of 20 mg/kg given by intravenous infusion on the first day of each 3-week cycle. Initially, four cycles are given before surgery, which is performed about four weeks after the last dose. After surgery, AK112 treatment resumes four to eight weeks later and continues every three weeks for up to 12 months or until disease progression or other reasons for stopping treatment occur. The study monitors patients closely during these treatment phases. Throughout the trial, participants undergo evaluations including imaging to confirm no lymph node or distant metastases before surgery, laboratory tests to assess organ function, and regular monitoring for safety and disease status. The primary outcome measured is progression-free survival up to one year. Patients are monitored until disease progression, intolerable side effects, withdrawal, or other specified endpoints. The total participation duration varies but includes preoperative treatment, surgery, postoperative treatment, and follow-up assessments.
CONDITIONS
Brief 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 written informed consent before any trial-related procedures.
- Male or female aged between 18 and 75 years.
- ECOG performance status score of 0 to 1.
- Histologically or cytologically confirmed hepatocellular carcinoma (HCC) or meets clinical diagnosis criteria.
- No prior treatment for HCC before surgery.
- No lymph node invasion or distant metastasis on preoperative imaging.
- Suitable for radical surgery as determined by the investigator.
- At least one postoperative high-risk factor for HCC recurrence (e.g., single lesion over 5 cm, vascular invasion, multiple tumor nodules, Edmondson grade II or higher, specific AFP levels, tumor adjacent to blood vessels, or incomplete tumor capsule).
- Child-Pugh score of A or B7.
- Expected survival of more than 3 months.
- At least one measurable lesion per RECIST 1.1 criteria.
- Normal thyroid hormone levels or asymptomatic abnormal T3/free T3/free T4.
- Adequate organ and bone marrow function based on specific lab values.
- Negative pregnancy test for women of childbearing potential before first dose.
- Use of effective contraception during treatment and for 120 days after last dose (or 180 days after last chemotherapy).
You will not qualify if you...
- Diagnosis of fibrolamellar HCC, sarcomatoid HCC, cholangiocarcinoma, or similar liver cancers.
- Other malignancies within 5 years except certain treated skin and bladder cancers.
- History of hepatic encephalopathy or liver transplantation.
- Cancer thrombus in major veins.
- Active hepatitis B or C infection above specified viral load thresholds.
- Symptomatic pleural effusion, ascites, or pericardial effusion needing drainage.
- Recent esophagogastric variceal bleeding or significant varices.
- History of bleeding disorders or recent significant bleeding.
- Recent arterial or venous thromboembolism or certain cardiovascular events.
- History of serious heart conditions or uncontrolled hypertension.
- Certain lung diseases, autoimmune diseases requiring systemic treatment, or immunodeficiency.
- Known active tuberculosis or syphilis.
- Severe or recent infections requiring systemic treatment.
- Prior systemic chemotherapy, bevacizumab, immunotherapy, or local liver therapies.
- Recent use of systemic anti-tumor traditional Chinese medicine or immunomodulatory drugs.
- Recent live vaccine administration.
- Allergy to study drug components or severe monoclonal antibody hypersensitivity.
- Known psychiatric illness, substance abuse, pregnancy, or breastfeeding.
- Any other condition that may interfere with study participation or safety as judged by the investigator.
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 15 months (including 4 cycles before surgery, 4 weeks until surgery, and up to 12 months after surgery)
Participants receive AK112 by intravenous infusion on day 1 of each 3-week cycle. They receive four cycles before surgery. Surgery is performed four weeks after the last preoperative dose. After surgery, participants receive AK112 again every 3 weeks for up to 12 months or until disease progression, intolerable toxicity, withdrawal, or other protocol-specified reasons.
Every 3 weeks for infusion cycles before and after surgery
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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