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HCCPhase 4NCT06930573

A Study of AK112, a PD-1/ VEGF Bispecific Antibody, for Resectable Hepatocellular Carcinoma With High Recurrence Risk

A Phase 4 study testing AK112 in people with HCC, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
HCC
What is being tested?
AK112
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
4 Dec 2024to 24 Dec 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Signed written informed consent before any trial-related procedures. 2. Male or female aged between 18 and 75 years. 3. ECOG PS score 0-1. 4. Histologically/cytologically confirmed hepatocellular carcinoma (HCC) or meets clinical diagnosis criteria (per 2022 Chinese Primary Liver Cancer Diagnosis and Treatment Guidelines).
  • 5. No preoperative HCC treatment (including chemotherapy, targeted therapy, immunotherapy, cell therapy, local radiotherapy, ablation, or intervention). No lymph node invasion/distant metastasis on preoperative imaging, and deemed suitable for radical surgery by the investigator.
  • 6. At least one postoperative high-risk factor for HCC recurrence:
  • Single lesion more than 5 cm in longest diameter.
  • Microvascular or macrovascular invasion.
  • More than 3 tumor nodules.
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  • Edmondson grade at least II on tumor pathology.
  • AFP more than 400 μg/L in CNLC Ib-IIa patients.
  • Tumor adjacent to blood vessels in CNLC Ib-IIa patients.
  • Incomplete tumor capsule in CNLC Ib-IIa patients. 7. Child-Pugh score A or B7. 8. Expected survival more than 3 months. 9. At least one measurable lesion per RECIST 1.1. 10. Total T3 or free T3 and free T4 within normal range (thyroid replacement therapy allowed). Asymptomatic subjects with abnormal T3, free T3, or free T4 are eligible.
  • 11. Adequate organ and bone marrow function, with laboratory values meeting the following criteria within 7 days before randomization (no blood products, growth factors, albumin, or corrective treatments within 14 days before obtaining these results):
  • Hematology: ANC at least 1.5×10⁹/L; PLT at least 75×10⁹/L; HGB at least 9.0 g/dL.
  • Liver function: TBIL at most 3×ULN; ALT, AST, ALP at most 5×ULN; serum albumin at least 28 g/L.
  • Renal function: Serum creatinine at most 1.5×ULN or CCr at least 50 mL/min (Cockcroft-Gault formula); urine protein less than 2+ on urinalysis. For subjects with baseline urine protein at least 2+, 24-hour urine protein less than 1 g.
  • Coagulation: INR and APTT at most 1.5×ULN. 12. For female subjects of childbearing potential, a negative urine or serum pregnancy test within 3 days before the first study drug administration (Cycle 1, Day 1). If urine test is inconclusive, a blood pregnancy test is required. Postmenopausal females (for at least 1 year), surgically sterilized, or hysterectomized are not of childbearing potential.
  • 13. All subjects with pregnancy risk must use effective contraception throughout treatment until 120 days after the last study drug dose (or 180 days after last chemotherapy dose).

Who cannot join

  • Past histological/cytological diagnosis of fibrolamellar hepatocellular carcinoma (HCC), sarcomatoid HCC, cholangiocarcinoma, etc.
  • Other malignancies within 5 years before enrollment, except those locally treated HCC. Exceptions include basal/squamous cell skin cancer, superficial bladder cancer, cervical/ breast carcinoma in situ.
  • History of hepatic encephalopathy or liver transplantation.
  • Cancer thrombus in portal vein branches, superior mesenteric vein, or inferior vena cava.
  • Active hepatitis B/C infection, with HBV DNA more than 2000 IU/ml or 10⁴ copies/ml; HCV RNA more than 10³ copies/ml; co-positive HBsAg and anti-HCV. Those on antiviral therapy meeting the above criteria and willing to continue during the study are eligible.
  • Clinically symptomatic pleural effusion, ascites, or pericardial effusion requiring drainage.
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  • Esophagogastric variceal bleeding due to portal hypertension within 6 months before first dose; current imaging shows significant esophagogastric varices.
  • History of significant bleeding tendency/coagulopathy; clinically significant bleeding within 1 month before first dose (e.g., GI bleeding, hemoptysis, epistaxis); continuous antiplatelet/anticoagulant therapy within 10 days before first dose.
  • Arterial/venous thromboembolism within past 6 months, including myocardial infarction, unstable angina, stroke, transient ischemic attack, pulmonary embolism, deep vein thrombosis. Exceptions: stable thrombosis after routine anticoagulation for implanted venous ports/ catheters or superficial vein thrombosis; low-dose LMWH (e.g., enoxaparin 40 mg/day) allowed.
  • History of myocarditis, cardiomyopathy, malignant arrhythmias. Unstable angina, MI, CHF (NYHA ≥Class 2), or vascular disease requiring hospitalization within 12 months before first dose; other cardiac impairments affecting drug safety assessment. Severe ulcers, unhealed wounds, GI perforation, fistula, obstruction, abscess, or acute GI bleeding within 6 months before first dose; thromboembolic events, TIA, stroke within 6 months before first dose; COPD exacerbation, hypertensive crisis/encephalopathy within 1 month before first dose; current hypertension uncontrolled by oral medication (systolic BP more than 150 mmHg or diastolic BP more than 90 mmHg).
  • History or current non-infectious pneumonia/interstitial lung disease requiring systemic corticosteroids; active or past definite inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, chronic diarrhea); active autoimmune disease requiring systemic treatment within past 2 years (e.g., DMARDs, corticosteroids, immunosuppressants). Replacement therapy (e.g., thyroid hormones, insulin, physiological corticosteroids for adrenal/pituitary insufficiency) is not considered systemic treatment.
  • History of immunodeficiency; positive HIV antibody test; current long-term use of systemic corticosteroids or other immunosuppressants (except short-term corticosteroids for COPD-related dyspnea or temporary allergy prevention).
  • Known active tuberculosis (TB); suspected active TB requires clinical exclusion; known active syphilis infection.
  • Severe infection within 4 weeks before first dose (e.g., requiring hospitalization, sepsis, severe pneumonia); active infection treated with systemic anti-infectives within 2 weeks before first dose (excluding antiviral therapy for hepatitis B/C).
  • Past systemic chemotherapy or bevacizumab/biosimilar treatment.
  • Past immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1/L1, CTLA-4, CD47, SIRPα, LAG-3 antibodies), immune checkpoint agonists (e.g., ICOS, CD40, CD137, GITR, OX40 antibodies), or any immunotherapy targeting tumor immune mechanisms.
  • Past local therapy for liver lesions, including TACE, TARE, HAIC, or radiotherapy.
  • Systemic anti-tumor traditional Chinese medicine or immunomodulatory drugs (e.g., thymosin, interferon, interleukin) within 2 weeks before first dose (except those locally used to control pleural/ascitic fluid).
  • Live/attenuated vaccine administration within 30 days before first dose or planned during study; inactivated vaccines are allowed.
  • Known allergy to any study drug component; history of severe hypersensitivity to other monoclonal antibodies.
  • Known psychiatric disease, drug abuse, alcoholism, or substance addiction.
  • Pregnant or breastfeeding women.
  • Any condition, disease, or abnormality that may interfere with study results, hinder study participation, or pose additional risk, as determined by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450000

    Zujiang Yu, MD, 0371-67966942, johnyuem@zzu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: 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

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
HCC
Being tested
AK112

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AK112Drug

    After enrollment, patients receive AK112 at 20 mg/kg, administered via intravenous infusion on day 1 of each cycle, every 3 weeks (Q3W). After four cycles, surgery is performed four weeks after the last dose. AK112 at 20 mg/kg is administered again four to eight weeks after surgery, via intravenous infusion on day 1 of each cycle, every 3 weeks (Q3W), until disease progression, death, intolerable toxicity, withdrawal of consent, initiation of new anti-tumor therapy, or other reasons specified in the protocol for discontinuation of treatment. The maximum postoperative treatment duration with AK112 is 12 months.

Study groups in NCT06930573
Study groupRoleWhat they receive
Resectable Hepatocellular Carcinoma With High Recurrence RiskExperimentalNot described
Receives: Drug: AK112

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    Progression-free survival is defined as the time from the start of treatment with AK112 until the first documentation of disease progression or death due to any cause, whichever occurs first.

    Measured: Up to 1 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2025
  2. Study start4 Dec 2024
  3. Primary completion24 May 2026 (estimated)
  4. Study completion24 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06930573
Sponsor's protocol ID
L2024-K001-006
Status last verified
Feb 2025
First submitted
9 Apr 2025
Last updated
16 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing AK112 in people with HCC, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: Up to 1 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06930573.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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