A Study of the Application of Hepatic Arterial Infusion in Advanced Hepatocellular Carcinoma Previously Treated With Immune Checkpoint Inhibitors and Antiangiogenic Agents
Immune checkpoint inhibitors (ICIs) plus antiangiogenic agents can achieve better efficacy than sorafenib in the treatment of hepatocellular carcinoma (HCC) within a certain period of time, but more than half of the patients are still insensitive to the treatment. There is no evidence-based basis for second-line treatment after the progression of the disease.In view of the effectiveness of Hepatic arterial infusion (HAIC) in the first-line treatment of HCC in the Chinese population, this study intends to launch a prospective intervention study to explore the efficacy and safety of HAIC treatment in patients with advanced HCC after the failure of ICIs and antiangiogenic agents combination therapy, and to provide high-level evidence for optimizing the second-line treatment of advanced HCC in the future.
• Cytohistological confirmation is required for diagnosis of HCC. Patients with advanced (unresectable and/or metastatic, stage C based on Barcelona-Clinic Liver Cancer \[BCLC\] staging classification) hepatocellular carcinoma.
• At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1.
• Current cirrhotic status of Child-Pugh class A-B, with no encephalopathy. Ascites controlled by diuretics is permitted in this study.
• Availability of a representative tumor tissue specimen (archival tumor tissue is allowed) at pre-screening.
• Eastern Cooperative Oncology Group Scale for Assessment of Patient Performance Status ≤ 2.
• Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and 4 weeks after the completion of trial.
• Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to procedure:
• Hemoglobin \> 100g/L Absolute neutrophil count \>3.0 ×109/L Neutrophil count \> 1.5 ×109/L Platelet count ≥ 50.0 ×109/L Total bilirubin \< 51 μmol/L Alanine transaminase (ALT) and aminotransferase (AST) \< 5 x upper limit of normal Albumin \> 28 g/L Prothrombin time (PT)-international normalized ratio (INR) \< 2.3, or PT \< 6 seconds above control Serum creatinine \< 110 μmol/L Willing and able to comply with scheduled visits, treatment plan and laboratory tests.