A Study of Combination Therapy in Patients With Resectable Liver Cancer

Prior treatment

• 3\. Planned or prior organ transplantation or allogeneic bone marrow transplantation.
• 4\. Treatment with another investigational drug within 28 days before study treatment.
• 5\. Current or prior central nervous system metastases.
• 9\. Use of immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes within 14 days before study treatment.
• 10\. Severe infection within 4 weeks before study treatment.
• 11\. Gastrointestinal bleeding within 6 months before study treatment or a known risk of gastrointestinal bleeding.
• 15\. Major vascular disease within 6 months before study treatment.

Other illness

• 1\. Intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed hepatocellular carcinoma, fibrolamellar carcinoma, or any other active malignancy within the past 5 years (except HCC).
• 2\. Severe allergy to iodinated contrast agents that prevents HAIC treatment.
• 6\. History of hepatic encephalopathy.
• 7\. Current interstitial pneumonitis or interstitial lung disease.
• 8\. Active autoimmune disease or history of autoimmune disease with risk of recurrence.
• 12\. Known hereditary or acquired bleeding disorders or thrombotic tendency.
• 13\. Uncontrolled clinically significant cardiac disease or symptoms.
• 16\. Inability to swallow oral medication, malabsorption syndrome, or any condition affecting gastrointestinal absorption.
• 17\. Known hypersensitivity to any study drug, its excipients, monoclonal antibodies, or anti-angiogenic agents.

Lab values

• 18\. Any other serious acute or chronic medical condition, psychiatric disorder, or laboratory abnormality that may increase study risk, interfere with study results, or make the patient unsuitable for participation.

Other

• 14\. Moderate or severe ascites requiring therapeutic drainage or paracentesis.

• 1\. Voluntarily signed written informed consent.
• 2\. Age ≥18 years; male or female.
• 3\. Histologically, cytologically, or clinically confirmed hepatocellular carcinoma (HCC) according to EASL/AASLD criteria.
• 4\. CNLC stage Ib, IIa, IIb, or IIIa HCC (excluding patients with main portal vein tumor thrombus).
• 5\. Presence of vascular invasion and no extrahepatic metastasis, including PVTT (Vp1-Vp3), HVTT, or IVCTT.
• 6\. No prior systemic treatment for HCC, including chemotherapy, targeted therapy, or immunotherapy.
• 7\. Child-Pugh class A liver function.
• 8\. ECOG performance status 0-1.
• 9\. Adequate organ function:
  • ANC ≥1.5 × 10\^9/L; Platelet count ≥75 × 10\^9/L; Hemoglobin ≥90 g/L.
  • Albumin ≥30 g/L; Total bilirubin ≤1.5 × ULN; ALT, AST, and ALP ≤5 × ULN; Serum creatinine ≤1.5 × ULN or creatinine clearance \>50 mL/min.
  • INR ≤2.3 or PT prolongation ≤6 seconds.
  • Urine protein \<2+; if ≥2+, 24-hour urine protein \<1.0 g.
• 10\. For patients with active HBV infection, effective antiviral therapy is required, with HBV DNA ≤2000 IU/mL or a ≥10-fold reduction after antiviral treatment.
• 11\. Women of childbearing potential must have a negative pregnancy test before enrollment and agree to use effective contraception during the study and for 6 months after study completion. Male participants must also use effective contraception during the study and for 6 months after study completion.