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

Other illness

• Concurrent Malignancy
  • History of other malignancies within 5 years except:
• 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.

Other

• Pregnancy/Lactation Women who are pregnant or breastfeeding.
• Curatively treated basal cell carcinoma
  • Cervical carcinoma in situ
  • Papillary thyroid carcinoma

• \- 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.