Adjuvant TACE in HCC With High-risk Recurrence Factors

Inclusion criteria

• Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 at enrollment;
• Child-Pugh class A or B7 (score 5-7);
• having undergone radical hepatic resection at one of the study centers;
• histopathologically confirmed HCC;
• undergo hepatic angiography 4-8 weeks after surgery, with confirmation of no intrahepatic tumor staining;
• have no prior systemic anti-tumor therapy for HCC;
• have adequate organ and bone marrow function;
• estimated life expectancy >6 months;
• present with at least one high-risk factor for recurrence (such as tumor rupture; maximum tumor diameter >5 cm; multifocal tumors; microvascular invasion on postoperative pathology; Vp1/Vp2 portal vein invasion; lymph node metastasis confirmed by postoperative pathology; positive or narrow surgical margin; and Edmondson grade Ⅲ-Ⅳ differentiation).

Exclusion criteria

• absence of pathological confirmation of HCC;
• diagnosis of other malignancies within the 5 years prior to enrollment;
• a history of hepatic encephalopathy, liver transplantation, pleural effusion, ascites, or pericardial effusion with clinical symptoms after curative hepatectomy, as well as a history of drug allergy, active pulmonary tuberculosis, active syphilis infection, autoimmune disease, or long-term glucocorticoid use;
• participants who have experienced severe infections within 4 weeks before the first dose, or who have previously received systemic anti-tumor therapy;
• pregnant or lactating women are ineligible for participation;
• participants who are unable to comply with the treatment regimen or complete the follow-up requirements.