Apatinib Mesylate and Camrelizumab Combined With TACE as Neoadjuvant Therapy for Hepatocellular Carcinoma

Inclusion criteria

• 1) Diagnosed with hepatocellular carcinoma by pathological or histological examination.
• 2) the patient do not receive any anti-tumor treatment, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy and targeted therapy
• 3)resectable centrally-located hepatocellular carcinoma in BCLC stage B; Surgical resection was feasible after MDT discussion.
• 4) aged 18 to 70 years old, male or female
• 5) at least one measurable lesions (according to RECISTv1.1 requirements, The long diameter of the measurable lesion in the spiral CT scan is ≥10 mm or The short diameter of the enlarged lymph nodes is ≥15 mm)
• 6) ECOG score between 0 to 2, Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤5 ULN, total serum bilirubin TBIL ≤1.5 ULN, creatinine (Cr)≤1.5ULN, HB≥80g/L, neutrophil > 1.5×109/L ,Serum albumin > 28 g/L
• 7) Child - Pugh grade A or B (7 points or less); ICG - R15 < 20%
• 8) Sufficient future liver reserve (FLR): For patients with liver cirrhosis, FLR should be greater than 40% of the standard liver volume; for patients without liver cirrhosis, FLR should be greater than 30% of the standard liver volume.
• 9) After assessment, TACE treatment can be deemed suitable.
• 10) The subjects signed the informed consent form and voluntarily received the neoadjuvant treatment of Apatinib mesylate and Carlimzumab combined with TACE. They had good compliance and cooperated with the follow-up.

Exclusion criteria

• 1) Patients with intrahepatic cholangiocarcinoma (ICC), mixed hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or fibrolamellar hepatocellular carcinoma.
• 2) Patients with a history of malignant tumors other than liver cancer.
• 3) Patients with recurrent HCC after surgery who have received local or systemic treatment (chemotherapy, radiotherapy, surgery, interventional therapy, ablation, alcohol injection, or molecular targeted therapy).
• 4) Patients who are currently receiving or have previously received organ transplantation or allogeneic bone marrow transplantation, or have immune deficiency diseases or a history of organ transplantation.
• 5) Patients with vascular or biliary tumor thrombus or extrahepatic organ metastasis as shown by imaging.
• 6) Patients with moderate to severe ascites requiring therapeutic puncture and drainage or uncontrolled pleural effusion or pericardial effusion.
• 7) Patients with dysfunction of cardiovascular, respiratory, nervous, digestive, or urinary systems.
• 8) Patients with a history of gastrointestinal bleeding within 6 months before the start of the study, with a tendency to gastrointestinal bleeding, abdominal fistula, gastrointestinal perforation, or abdominal abscess.
• 9) Patients with multiple factors affecting oral drug administration (such as inability to swallow, chronic diarrhea, and intestinal obstruction, which significantly affect drug intake and absorption); patients allergic to the active ingredients or excipients of Camrelizumab and Apatinib mesylate.
• 10) Pregnant or lactating women; patients with reproductive capacity who are unwilling or unable to take effective contraceptive measures.
• 11) Patients with mental disorders or a history of abuse of psychotropic drugs.
• 12) Patients who have experienced thrombosis or embolism events within 6 months before the start of the study, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc.
• 13) Patients without legal capacity or with restricted legal capacity.
• 14) Patients with any other conditions that the investigator deems unsuitable for participation in this trial.