NCT06930573

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HCC

Interventions

Type	Name	Description
DRUG	AK112	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.

Timeline

• Start date: 2024-12-04
• Primary completion: 2026-05-24
• Completion: 2027-12-24
• First posted: 2025-04-16
• Last updated: 2025-04-16

Locations

1 site across 1 country: China