RecruitingPhase 4NCT06930573

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


Sponsor

The First Affiliated Hospital of Zhengzhou University

Enrollment

30 participants

Start Date

Dec 4, 2024

Study Type

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called AK112 — which blocks two proteins (PD-1 and VEGF) that allow cancer to hide from the immune system and grow new blood vessels — as an after-surgery (adjuvant) treatment for liver cancer (hepatocellular carcinoma, or HCC) with high risk of recurrence. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with liver cancer (HCC) and had it surgically removed - Your cancer had at least one high-risk feature suggesting it might come back (e.g., large tumor, vascular invasion, multiple nodules) - You have adequate liver, kidney, and blood function - You did not receive any other cancer treatment before surgery **You may NOT be eligible if...** - Your cancer had spread to lymph nodes or other organs before surgery - You received chemotherapy, immunotherapy, or other cancer treatment before your surgery - You have Child-Pugh Class C liver disease (severe liver failure) - You have autoimmune disease or certain active infections Talk to your doctor to see if this trial is right for you.

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

DRUGAK112

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)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

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NCT06930573


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