TACE Plus Sorafenib Versus TACE Alone for Recurrent Intermediate Hepatocellular Carcinoma

The trial will recruit 162 patients with recurrent intermediate HCC, and they will be randomized (1:1) into two groups (TACE+sorafenib group, TACE group). Patients in TACE+sorafenib group will receive TACE one day following oral sorafenib (initial dose: 400mg BID). Patients in the TACE group will receive TACE alone.

Inclusion criteria

• Age: 18-75 years;
• Diagnosed as HCC based on the American Association for the Study of Liver Diseases 2018 Guideline on Liver Cancer Diagnosis;
• Initial tumor recurrence following curative surgical resection (R0 hepatectomy) (two to three lesions with at least one lesion >3 cm in diameter or more than three lesions of any diameter). Tumor burden ≤ 50% and no distant metastasis and macroscopic vascular invasion;
• Histologically confirmed microvascular invasion in the specimen slices of surgically removed primary tumor;
• Eastern Cooperative Oncology Group scoring 0-1;
• Child-Pugh A class;
• At least 3 months of life expectancy;
• Adequate hematologic, hepatic and renal function: absolute neutrophil count ≥ 1.5x10^9/L, platelet ≥ 60 x10^9/L, Hb ≥ 90g/L, albumin ≥ 30g/L, total bilirubin ≤ 1.5 x upper limit of normal (ULN) , ALT < 5×ULN, AST < 5×ULN, alkaline phosphatase < 4×ULN, extended prothrombin time not exceeding 6s of ULN, creatine<1.5×ULN.

Exclusion criteria

• Have lesions which are diffuse or can not be evaluated via imaging. Tumor burden>50%;
• Have a history of hepatic encephalopathy, refractory ascites, severe esophageal and gastric varices or variceal bleeding and obstructive jaundice;
• Have contraindications for TACE;
• Have metastasis in central nervous system;
• Allergic to intravenous contrast agents;
• Pregnant or breastfeeding women, or expecting to conceive or father children within two years;
• Infection of HIV, known syphilis requiring treatment;
• Have a known history of prior invasive malignancies within 5 years before enrolment;
• Patients with allotransplantation;
• Severe dysfunction involving heart, kidney or other organs;
• Severe active clinical infection which is over grade 2 based on NCI-CTC version 4;
• Patients with mental disorders which may impact informed consent;
• Unable to orally take drugs;
• Participating other clinical drug trials 12 months before enrolment.