A Study of Combination Therapy in Patients With Resectable Liver Cancer (Archer)

Inclusion Criteria:

• 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:

  1. ANC ≥1.5 × 10^9/L; Platelet count ≥75 × 10^9/L; Hemoglobin ≥90 g/L.
  2. 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.
  3. INR ≤2.3 or PT prolongation ≤6 seconds.
  4. 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.

Exclusion Criteria:

• 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.
• 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.
• 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.
• 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.
• 12. Known hereditary or acquired bleeding disorders or thrombotic tendency.
• 13. Uncontrolled clinically significant cardiac disease or symptoms.
• 14. Moderate or severe ascites requiring therapeutic drainage or paracentesis.
• 15. Major vascular disease within 6 months before study treatment.
• 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.
• 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.