HCC
Conditions
Keywords
adjuvant regimen, TACE combined with targeted-immunotherapy
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 .
Interventions
DRUGFinotonlimab (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) .
PROCEDURETACE
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).
Sponsors
Tongji Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MPR | 9 weeks | Defined as the presence of ≥70% tumor necrosis in the tumor bed and regional lymph nodes of resected specimens following curative resection. |
| pCR | 9 weeks | Defined as the absence of viable tumor cells in both the primary tumor site and regional lymph nodes of resected specimens after curative surgery. |
| R0 rate | 9 weeks | The tumor was completely removed with negative margins, meaning no residual tumor |
| EFS | 2 years | Event Free Survival |
| safety | 2 years | Safety profiles during neoadjuvant therapy and postoperative period were systematically assessed per CTCAE v5.0 |
Countries
China
Outcome results
None listed