A Study of AK112, a PD-1/ VEGF Bispecific Antibody, for Resectable Hepatocellular Carcinoma With High Recurrence Risk
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
The First Affiliated Hospital of Zhengzhou University
30 participants
Dec 4, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
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.
Locations(1)
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NCT06930573