Hepatic Arterial Infusion Chemotherapy Combine With Lenvatinib and PD-1 Inhibitors for Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis.
The purpose of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy combined with Lenvatinib and PD-1 inhibitors compared to Lenvatinib plus PD-1 inhibitors for advanced hepatocellular carcinoma (HCC) with portal vein tumor thrombosis (PVTT).
• Age and gender: \>18 years old and≤75 years old, both men and women.
• All subjects must have advanced hepatocellular carcinoma with portal vein tumor thrombosis confirmed by pathological or clinical diagnosis.
• One measurable lesion at least.
• ECOG PS 0-1 before 1 week of treatment begnining.
• Child-Pugh class A; ALBI class 1-2.
• Systemic-cheomtherapy-naive and HAIC-naive.
• BCLC C stage with PVTT (Vp1 - Vp4).
• Without distant metastasis.
• Patients who are expected to live more than 3 months.
⁃ Subjects must volunteer to participate in the study, signed informed consent, and were able to comply with the program requirements of visits and related procedures.
⁃ Patients with laboratory values that meet the following criteria:
∙ Hemoglobin≥90 g/L;
‣ Neutrophile granulocytes≥1.5×109/L;
‣ Platelet count≥75×109/L;
‣ Albumin≥30 g/L;
‣ Total serum bilirubin ≤ 2 times upper limits of normal;
‣ AST and ALT ≤ 5 times upper limits of normal;
‣ Serum creatinine ≤ 1.5 times upper limits of normal;
‣ Alkaline phosphatase ≤ 5 times upper limits of normal;
‣ Prothrombin time or international normalized ratio ≤ 1.5 times upper limits of normal, activated partial thromboplastin time (APTT) ≤ 1.5×ULN.