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New treatment option for HCC
Official title A Study of AK112, a PD-1/ VEGF Bispecific Antibody, for Resectable Hepatocellular Carcinoma With High Recurrence Risk
ClinicalTrials.gov ID: NCT06930573
What this study is testing
What is AK112?
AK112 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hcc.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Single lesion more than 5 cm in longest diameter.
- Microvascular or macrovascular invasion.
- More than 3 tumor nodules.
- Edmondson grade at least II on tumor pathology.
You likely can't join if
- 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...
- 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...
- Clinically symptomatic pleural effusion, ascites, or pericardial effusion requiring drainage.
See the full eligibility criteria
Who can 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...
- Single lesion more than 5 cm in longest diameter.
- Microvascular or macrovascular invasion.
- More than 3 tumor nodules.
- 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...
- 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 people with baseline urine protein at least 2+, 24-hour urine protein...
- Coagulation: INR and APTT at most 1.5×ULN. 12. For female people 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...
What rules you out
- 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...
- Clinically symptomatic pleural effusion, ascites, or pericardial effusion requiring drainage.
- 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...
- 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...
- 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...
- 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)...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.