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

NCT ID: NCT07009470

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-10
• Study Completion Date: 2028-10-28

Brief 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 .

Conditions

HCC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TACE combined with targeted-immunotherapy

Group Type: EXPERIMENTAL

Finotonlimab (an anti-PD-1 monoclonal antibody) and Anbeizhu (a bevacizumab biosimilar)

Intervention Type: DRUG

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

Intervention Type: PROCEDURE

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).

Interventions

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) .

Intervention Type: DRUG

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).

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tongji Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhiyong Huang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhiyong Huang

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

Tongji Hospital

Wuhan, Hubei, China

Countries

China

Other Identifiers

HCC-SCT-TJ01

Identifier Type: -

Identifier Source: org_study_id