Observation Study of Sequential Regorafenib Combined With Immunocheckpoint Inhibitors After Hepatic Artery Infusion Chemotherapy for Advanced Hepatocellular Carcinoma
Hepatic artery infusion chemotherapy (HAIC) has shown promising outcomes in patients with advanced hepatocellular carcinoma (HCC). Some patients can be converted to loco-regional therapies after 4-6 cycles of HAIC treatment. But most of these patients still need to concern the sequential treatment after standard HAIC treatment (4-6 cycles). Combination of anti-angiogenic molecular targeted therapy and immune checkpoint inhibitor (ICI) therapy has shown promising antitumor activity in HCC. Regorafenib is one of the standard second-line systemic therapy for advanced HCC. In this study, we will evaluate the efficacy and safety of sequential therapies of Regorafenib plus ICI in patients with advanced HCC who have completed 4-6 cycles of HAIC.
⁃ Written informed consent must be obtained prior to any screening procedures.
• 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 who have completed 4-6 cycles HAIC. Treated efficacy evaluation has confirmed that these patients are not suitable for loco-regional therapies or surgical resection.
• At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1. Lesions previously treated with local therapy, such as radiation therapy, hepatic arterial embolization, radiofrequency ablation, and percutaneous interventional therapy should not be selected unless progression is noted at baseline, in which case, these lesions would be considered as non-target lesions.
• 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.