A Prospective, Single-Arm, Open-Label Clinical Study of the Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Combined With Targeted Therapy and a PD-1 Inhibitor in Patients With Postoperative Hepatocellular Carcinoma and Microvascular Invasion

A Prospective, Single-Arm, Open-Label Clinical Study of the Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Combined With Targeted Therapy and a PD-1 Inhibitor in Patients With Postoperative Hepatocellular Carcinoma and Microvascular Invasion

A Prospective, Single-Arm, Open-Label Clinical Study of the Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Combined with Targeted Therapy and a PD-1 Inhibitor in Patients with Postoperative Hepatocellular Carcinoma and Microvascular Invasion

Inclusion Criteria:

1. Age 18-80 years, male or female;

2. Pathologically confirmed hepatocellular carcinoma, with complete resection of all tumor nodules and negative surgical margins;

3. Microvascular invasion (MVI) grade ≥ 1

4. No other history of tumors and no preoperative anticancer treatment.

5. ECOG: 0-1;

6. Baseline blood count tests and blood biochemistry must meet the following criteria:

   Hemoglobin ≥80 g/L;

   Absolute neutrophil count ≥1.5×109/L;

   Platelet count ≥50×109/L;

   Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 times the upper limit of normal (ULN);

   Total bilirubin ≤3 times ULN;

   Serum creatinine ≤1.5 times ULN;

   Albumin ≥28 g/L; prothrombin time (PT) ≤19.5 s;

   International normalized ratio (INR) ≤2.3

7. Women of childbearing potential must agree to use contraception during the study and for 6 months after the study ends (e.g., intrauterine device, oral contraceptives, or condoms); serum or urine pregnancy test must be negative within 7 days before enrollment, and they must not be breastfeeding; men must agree to use contraception during the study and for 6 months after the study ends;

8. Subjects voluntarily participate in this study, sign the informed consent form, are compliant, and cooperate with follow-up.

Exclusion Criteria:

• 1. Patients with any active autoimmune disease or a history of autoimmune disease (including, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; patients whose childhood asthma has completely resolved and who require no intervention as adults may be included; asthma requiring bronchodilator intervention for medical management cannot be included);

  2. Pregnancy or lactation;

  3. Over 80 years old;

  4. Prior systemic chemotherapy or radiotherapy;

  5. Concomitant malignant pleural effusion or ascites;

  6. History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation);

  7. Concomitant infection requiring anti-infective treatment;

  8. Concomitant peripheral nervous system disease or a history of significant psychiatric disease and central nervous system disease;

  9. Diagnosis of other types of malignant tumors within 5 years, excluding non-melanoma skin cancer and carcinoma in situ of the cervix;

  10. Uncorrectable coagulation disorders;

  11. Significant ECG abnormalities or obvious clinical symptoms of heart disease, such as congestive heart failure (CHF), clinically significant coronary heart disease, difficult-to-control arrhythmias, and hypertension;

  12. History of myocardial infarction within 12 months, or cardiac function class III or IV;

  13. Severe liver disease (e.g., cirrhosis), kidney disease, respiratory disease, uncontrolled diabetes, or other systemic diseases;

  14. Individuals deemed unsuitable for inclusion by the investigator.