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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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TACE combined with targeted-immunotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) . |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| MPR | Defined as the presence of ≥70% tumor necrosis in the tumor bed and regional lymph nodes of resected specimens following curative resection. | 9 weeks |
| pCR | Defined as the absence of viable tumor cells in both the primary tumor site and regional lymph nodes of resected specimens after curative surgery. |
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Inclusion Criteria:
- 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.
Exclusion Criteria:
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.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Zhiyong Huang | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital | Wuhan | Hubei | China |
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| 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). |
|
| 9 weeks |
| R0 rate | The tumor was completely removed with negative margins, meaning no residual tumor | 9 weeks |
| EFS | Event Free Survival | 2 years |
| safety | Safety profiles during neoadjuvant therapy and postoperative period were systematically assessed per CTCAE v5.0 | 2 years |