Hepatic arterial infusion chemotherapy and immunotherapy for liver cancer

Inclusion Criteria:

1. Aged between 18 and 75 years;
2. Preoperative pathological diagnosis or clinically diagnosed liver cancer meeting EASL/AASLD diagnostic criteria. No prior systemic chemotherapy, immunotherapy, targeted therapy, or other anti-tumor treatments for HCC;
3. Staging in BCLC Stage A or B, and beyond the Up-to-Seven criteria but deemed resectable (negative margins and remaining liver volume sufficient to meet body needs);
4. ECOG performance status score of 0 before the first medication in the study;
5. Liver function classified as Child-Pugh Class A and ICG retention rate at 15 minutes ≤ 10%;
6. Estimated survival time of at least 6 months;
7. Organ function levels meet the requirements and are capable of tolerating surgery before the first medication in the study; Key organ function indicators must meet the following criteria: Hemoglobin ≥ 90 g/L, Neutrophil count ≥ 1.5 × 10⁹/L, Platelet count ≥ 100 × 10⁹/L; Aspartate or Alanine aminotransferase ≤ 5 times the upper limit of normal (ULN), Alkaline phosphatase ≤ 2.5 ULN, Serum albumin ≥ 30 g/L; Serum creatinine \< 1.5 ULN; International Normalized Ratio (INR) ≤ 2 or Prothrombin Time (PT) exceeding the upper limit of normal ≤ 6 seconds; Serum creatinine ≤ 1.5 ULN, Creatinine clearance ≥ 60 mL/min.
8. Male and female participants with reproductive potential must agree to use effective contraception throughout the study period;
9. Sign a consent form agreeing to provide previously stored blood samples, tumor tissue specimens, or fresh biopsy tumor lesions.

Exclusion Criteria:

1. Pathological diagnosis of non-hepatocellular carcinoma;
2. Previous treatment for liver cancer-related chemotherapy, radiotherapy, radiofrequency ablation, interventional therapies and targeted therapy, immunotherapy, or surgical procedures (excluding prior non-tumor-related surgeries or diagnostic biopsies);
3. Preoperative assessment indicates the tumor is unresectable;
4. Viral load limitations: hepatitis B virus (HBV) DNA \> 2000 copies/ml, hepatitis C virus (HCV) RNA \> 1000;
5. Long-term hormone users require ongoing systemic hormone treatment (equivalent to \> 10 mg prednisone/day) or any other form of immunosuppressive therapy;
6. Clinical significant bleeding events or bleeding tendencies within 3 months prior to enrollment or currently receiving thrombolytic or anticoagulant treatment;
7. History of autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, etc.;
8. Active severe clinical infection (\> Grade 2, NCI-CTCAE Version 5.0), including active tuberculosis; history of active tuberculosis infection within the past year without receiving formal anti-tuberculosis treatment or ongoing active tuberculosis; known or suspected active autoimmune diseases;
9. Uncontrolled diabetes (fasting blood glucose ≥ 10 mmol/L), severe lung disease (such as acute lung disease, pulmonary fibrosis affecting lung function, interstitial lung disease. However, resolved radiation pneumonitis is excluded);
10. Clinically significant cardiovascular disease; hypertension that is poorly controlled by antihypertensive medications (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg);
11. Recipients of renal replacement therapy;
12. History of other malignancies within the last 5 years. However, cured skin basal cell carcinoma or cervical carcinoma in situ is excluded;
13. Other conditions that are expected to render the participant unable to tolerate surgical treatment;
14. Allergic reactions to any components of the study drug;
15. Presence of alcohol dependence, mental illnesses, pregnancy (or breastfeeding), or other conditions that make participation in clinical trials inappropriate.