Evaluating the Safety and Effectiveness of AK112 Treatment Before and After Surgery in Adults With Resectable Liver Cancer at High Risk of Coming Back

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 mgkg 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.

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