A Multicenter, Prospective Study of Perioperative Finotonlimab Combined With Bevacizumab in Resectable Hepatocellular Carcinoma Patients With High-Risk Factors for Recurrence

Inclusion criteria

• - Informed Consent Voluntarily signed informed consent after full understanding of the study, with commitment to comply with all protocol requirements and assessment schedules.
• Age 18-75 years inclusive.
• Diagnosis Histologically/cytologically confirmed hepatocellular carcinoma (HCC) OR clinically diagnosed HCC per 2024 Chinese Guidelines for Primary Liver Cancer.
• Tumor Status

Meets ONE of the following:

Multifocal tumors (2-4 lesions)

Single lesion >5 cm in longest diameter

Stage IIIa HCC with Vp1/Vp2/Vp3 portal vein tumor thrombus

• Resectability Technically amenable to curative resection per surgeon assessment.
• Liver Function Child-Pugh class A.
• Performance Status ECOG PS 0-1.
• Prior Therapy No previous systemic treatment for HCC.
• Measurable Disease

≥1 radiologically measurable lesion per mRECIST.

• Organ Function (1) Hematological:

ANC ≥1.5×10⁹/L

Hemoglobin ≥90 g/L

Platelets ≥50×10⁹/L (2) Hepatic:

Total bilirubin ≤1.5×ULN

AST/ALT ≤2.5×ULN

Albumin ≥28 g/L (3) Coagulation:

INR ≤2.3 OR PT prolongation ≤3 sec vs control (4) Renal:

eGFR >90 mL/min/1.73m² (CKD-EPI)

• Contraception

Women of childbearing potential: Negative serum pregnancy test within 7 days prior to enrollment.

All subjects: Use highly effective contraception during treatment and for 180 days post-last dose.

Exclusion criteria

• Pregnancy/Lactation Women who are pregnant or breastfeeding.
• Concurrent Malignancy

History of other malignancies within 5 years except:

• Curatively treated basal cell carcinoma

Cervical carcinoma in situ

Papillary thyroid carcinoma

• Drug Hypersensitivity Known allergy to finolizumab, bevacizumab, or their excipients.

Bleeding Risk History of upper GI bleeding OR active hemorrhagic disorders.

• Uncontrolled Cardiac Disease

Clinically significant cardiac conditions including:

NYHA Class II+ heart failure

Unstable angina

Myocardial infarction within 1 year

Clinically significant arrhythmias requiring intervention

• Autoimmune Disorders Active autoimmune diseases or history of autoimmune disorders.
• Immunodeficiency

Immunodeficiency conditions including:

HIV positive status

Primary/secondary immunodeficiency

History of organ/bone marrow transplantation

• Psychiatric Conditions Severe psychiatric disorders OR substance abuse involving psychotropic drugs.
• Uncontrolled Comorbidities Severe uncontrolled recurrent infections OR other significant uncontrolled comorbidities.
• Investigator Discretion Any condition deemed ineligible by the investigator.