Clinical trial NCT07009470: A Multicenter, Prospective Study of Perioperative Finotonlimab Combined With Bevacizumab in Resectable Hepatocellular Carcinoma Patients With High-Risk Factors for Recurrence
Official title: A Multicenter, Prospective Study of Perioperative Finotonlimab Combined With Bevacizumab in Resectable Hepatocellular Carcinoma Patients With High-Risk Factors for Recurrence
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HCC
Keywords: adjuvant regimen
TACE combined with targeted-immunotherapy
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 .


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.

Primary outcomes:
measure: 2-year DFS rate and 2-year OS rate
timeFrame: 2years
Secondary outcomes:
measure: MPR
timeFrame: 9 weeks
measure: pCR
timeFrame: 9 weeks
measure: R0 rate
timeFrame: 9 weeks
measure: EFS
timeFrame: 2 years
measure: safety
timeFrame: 2 years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Zhiyong Huang
role: PRINCIPAL_INVESTIGATOR
References: