A Multicenter, Prospective Study of Perioperative Finotonlimab Combined With Bevacizumab in Resectable Hepatocellular Carcinoma Patients With High-Risk Factors for Recurrence
Finotonlimab (an anti-PD-1 monoclonal antibody) and Anbeizhu (a bevacizumab biosimilar)TACE
Finotonlimab (an anti-PD-1 monoclonal antibody) and Anbeizhu (a bevacizumab biosimilar): First, perform a single session of TACE. Followed by three cycles of neoadjuvant therapy with Finotonlimab combined with bevacizumab. Proceed with curative resection. Finally, initiate postoperative adjuvant targeted-immunotherapy . Finotonlimab: intravenously every three weeks ,200mg. bevacizumab:intravenously every three weeks , with a dosage based on body weight: 15 mg (≤60 kg) .
TACE: Initial Perform a single session of TACE procedure.TACE treatment is strictly in accordance with the Chinese guidelines for clinical practice of transcatheter arterial chemoembolization (TACE) for hepatocellular carcinoma (2023 Edition).
Study summary
For patients with early- to mid-stage hepatocellular carcinoma (HCC), the five-year postoperative recurrence and metastasis rate remains as high as 70%, significantly impacting patient prognosis.Therefore, perioperative therapy may be considered for HCC patients with these high-risk features .
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. \- Informed Consent Voluntarily signed informed consent after full understanding of the study, with commitment to comply with all protocol requirements and assessment schedules.
2. Age 18-75 years inclusive.
3. Diagnosis Histologically/cytologically confirmed hepatocellular carcinoma (HCC) OR clinically diagnosed HCC per 2024 Chinese Guidelines for Primary Liver Cancer.
4. 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
5. Resectability Technically amenable to curative resection per surgeon assessment.
6. Liver Function Child-Pugh class A.
7. Performance Status ECOG PS 0-1.
8. Prior Therapy No previous systemic treatment for HCC.
9. Measurable Disease
≥1 radiologically measurable lesion per mRECIST.
10. 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)
11. 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:
1. Pregnancy/Lactation Women who are pregnant or breastfeeding.
2. Concurrent Malignancy
History of other malignancies within 5 years except:
3. Curatively treated basal cell carcinoma
Cervical carcinoma in situ
Papillary thyroid carcinoma
4. Drug Hypersensitivity Known allergy to finolizumab, bevacizumab, or their excipients.
Bleeding Risk History of upper GI bleeding OR active hemorrhagic disorders.
5. 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
6. Autoimmune Disorders Active autoimmune diseases or history of autoimmune disorders.
7. Immunodeficiency
Immunodeficiency conditions including:
HIV positive status
Primary/secondary immunodeficiency
History of organ/bone marrow transplantation
8. Psychiatric Conditions Severe psychiatric disorders OR substance abuse involving psychotropic drugs.
9. Uncontrolled Comorbidities Severe uncontrolled recurrent infections OR other significant uncontrolled comorbidities.
10. Investigator Discretion Any condition deemed ineligible by the investigator.
Primary outcome measure(s)
2-year DFS rate and 2-year OS rate — 2years 2-year DFS rate refers to the proportion of patients remaining free of disease recurrence or death for over 2 years, measured from the date of surgery.
2-year OS rate refers to the proportion of subjects surviving in the trial cohort at the 2-year follow-up mark, calculated from the initiation of neoadjuvant therapy.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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