Neoadjuvant Tislelizumab-Lenvatinib vs Surgery Alone in Stage Ia HCC With Narrow Margin

Inclusion Criteria

• •1. The patient voluntarily participates in this study and provides written informed consent.
• •2. Age ≥18 years at the time of consent; male or female.
• •3. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1.
• •4. Child-Pugh class A hepatic function.
• •5. Histologically/cytologically confirmed, or clinically diagnosed according to accepted diagnostic criteria, primary hepatocellular carcinoma (HCC), with a single tumor measuring 2-5 cm in greatest diameter (CNLC stage IA).
• •6. At enrollment, the lesion meets the criteria for surgically resectable disease per the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2024 edition); and an anticipated narrow surgical margin (resection margin \<1 cm) is expected due to tumor size and/or location, including any of the following:
• •* Lesion adjacent to the main trunk of the portal vein or first-order branches;
• •* Lesion adjacent to the inferior vena cava or the root of the hepatic veins;
• •* Lesion located in the caudate lobe.
• •7. No prior local or systemic antitumor therapy for HCC.
• •8. At least one measurable lesion per RECIST v1.1.
• •9. Adequate function of major organs within 14 days prior to initiation of study treatment, as defined below:
• •(1) Hematology (no blood transfusion within 14 days before screening; no granulocyte colony-stimulating factor \[G-CSF\] use; and no pharmacologic correction except for hemoglobin): absolute neutrophil count (ANC) ≥1.5×10\^9/L; platelets ≥75×10\^9/L; hemoglobin ≥90 g/L.
• •(2) Serum chemistry (no albumin infusion within 14 days before screening): serum albumin ≥29 g/L; total bilirubin ≤1.5× upper limit of normal (ULN); alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤5×ULN; serum creatinine ≤1.5×ULN or creatinine clearance (CrCl) \>50 mL/min (Cockcroft-Gault formula below).
• •Male: CrCl = (140 - age) × weight / (72 × serum Cr) Female: CrCl = \[(140 - age) × weight / (72 × serum Cr)\] × 0.85 Weight in kg; serum Cr in mg/dL. (3) International normalized ratio (INR) ≤2.3, or prothrombin time (PT) prolongation ≤6 seconds above the institutional normal control.
• •(4) Urine protein \<2+; if urine protein is ≥2+, a 24-hour urine protein quantification may be performed, and patients with 24-hour urine protein \<1.0 g are eligible.
• •10\. Viral hepatitis management:
• •For patients with active hepatitis B virus (HBV) infection: HBV DNA must be \<500 IU/mL (if the site reports in copies/mL only, \<2,500 copies/mL), and the patient must have received anti-HBV therapy for at least 14 days before initiation of study treatment (per local standard of care, e.g., entecavir) and be willing to continue antiviral therapy throughout the study.
• •Patients who are hepatitis C virus (HCV) RNA positive must receive antiviral therapy per local standard treatment guidelines, and liver function abnormalities must be no greater than CTCAE Grade 1.
• •11\. Contraception: Women of childbearing potential must agree to use effective contraception (e.g., intrauterine device, oral contraceptives, or condoms) during study treatment and for 6 months after the last dose; a negative serum or urine pregnancy test within 7 days prior to enrollment is required; women must not be breastfeeding. Male participants must agree to use effective contraception during the study and for 6 months after the end of the study.
• •12\. The participant is able and willing to comply with the protocol requirements and follow-up schedule.