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

NCT07009470 | Active Not Recruiting DMC

• 1 other identifier: HCC-SCT-TJ01
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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

Keywords

adjuvant regimen; TACE combined with targeted-immunotherapy

Outcome Measures

Primary Outcomes (1)

• 2-year DFS rate and 2-year OS rate

  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.

  2years

Secondary Outcomes (5)

• MPR

  9 weeks

• pCR

  9 weeks

• R0 rate

  9 weeks

• EFS

  2 years

• safety

  2 years

Study Arms (1)

TACE combined with targeted-immunotherapy

EXPERIMENTAL

Drug: Finotonlimab (an anti-PD-1 monoclonal antibody) and Anbeizhu (a bevacizumab biosimilar); Procedure: TACE

Interventions

Finotonlimab (an anti-PD-1 monoclonal antibody) and Anbeizhu (a bevacizumab biosimilar) 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 combined with targeted-immunotherapy

TACE 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).

TACE combined with targeted-immunotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, China

Location

Study Officials

• Zhiyong Huang

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 6, 2025
• Study Start: February 10, 2025
• Primary Completion (Estimated): April 28, 2028
• Study Completion (Estimated): October 28, 2028
• Last Updated: June 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)