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

Korábbi kezelés

• 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);
  • Pregnancy or lactation;
  • Over 80 years old;
  • Prior systemic chemotherapy or radiotherapy;
  • Concomitant malignant pleural effusion or ascites;
  • History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation);
  • Concomitant infection requiring anti-infective treatment;
  • Concomitant peripheral nervous system disease or a history of significant psychiatric disease and central nervous system disease;
  • Diagnosis of other types of malignant tumors within 5 years, excluding non-melanoma skin cancer and carcinoma in situ of the cervix;
  • Uncorrectable coagulation disorders;
  • 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;
  • History of myocardial infarction within 12 months, or cardiac function class III or IV;
  • Severe liver disease (e.g., cirrhosis), kidney disease, respiratory disease, uncontrolled diabetes, or other systemic diseases;
  • Individuals deemed unsuitable for inclusion by the investigator.

• Age 18-80 years, male or female;
• Pathologically confirmed hepatocellular carcinoma, with complete resection of all tumor nodules and negative surgical margins;
• Microvascular invasion (MVI) grade ≥ 1
• No other history of tumors and no preoperative anticancer treatment.
• ECOG: 0-1;
• 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
• 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;
• Subjects voluntarily participate in this study, sign the informed consent form, are compliant, and cooperate with follow-up.