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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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‣ 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 meets clinical diagnosis criteria (per 2022 Chinese Primary Liver Cancer Diagnosis and Treatment Guidelines).

‣ 5\. No preoperative HCC treatment (including chemotherapy, targeted therapy, immunotherapy, cell therapy, local radiotherapy, ablation, or intervention). No lymph node invasion/distant metastasis on preoperative imaging, and deemed suitable for radical surgery by the investigator.

‣ 6\. At least one postoperative high-risk factor for HCC recurrence:

• 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 range (thyroid replacement therapy allowed). Asymptomatic subjects with abnormal T3, free T3, or free T4 are eligible.

• 11\. Adequate organ and bone marrow function, with laboratory values meeting the following criteria within 7 days before randomization (no blood products, growth factors, albumin, or corrective treatments within 14 days before obtaining these results):

⁃ 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 subjects with baseline urine protein at least 2+, 24-hour urine protein less than 1 g.

⁃ Coagulation: INR and APTT at most 1.5×ULN. 12. For female subjects 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 test is inconclusive, a blood pregnancy test is required. Postmenopausal females (for at least 1 year), surgically sterilized, or hysterectomized are not of childbearing potential.

• 13\. All subjects with pregnancy risk must use effective contraception throughout treatment until 120 days after the last study drug dose (or 180 days after last chemotherapy dose).

Locations
Other Locations
China
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Time Frame
Start Date: 2024-12-04
Estimated Completion Date: 2027-12-24
Participants
Target number of participants: 30
Treatments
Experimental: Resectable Hepatocellular Carcinoma With High Recurrence Risk
Related Therapeutic Areas
Sponsors
Leads: The First Affiliated Hospital of Zhengzhou University

This content was sourced from clinicaltrials.gov