SBRT Plus Lenvatinib and TACE for Advanced Primary HCC: A Phase 3 Trial (SEARCH)

Inclusion criteria

• Age 18-75 years old;
• Patients with primary advanced HCC (in accordance with AASLD2018 guidelines for the diagnosis of HCC), without any previous treatment;
• There is at least one measurable lesion in the liver according to mRECIST criteria, single tumor ≤ 10.0 cm or multiple tumors and tumor burden ≤50% , with portal vein tumor embolus;
• ECOG score 0-1;
• Child-Pugh class A;
• Expected survival time ≥ 3 months;
• Blood, liver and kidney function meet the following conditions: Neutrophil count ≥ 1.5 × 10 9 /L; Platelet count ≥ 60 × 10 9 /L; Hemoglobin ≥ 90 g/L; Serum albumin ≥ 30 g/L; Bilirubin ≤ 50 umol/L; AST, ALT ≤ 5 times the upper limit of normal, ALP ≤ 4 times the upper limit of normal; Prolongation of prothrombin time not to exceed the upper limit of normal by 6 seconds; Creatinine ≤ 1.5 times the upper limit of normal.

Exclusion criteria

• Extrahepatic metastases;
• Previous history of liver or adjacent tissue radiation;
• Previous history of hepatic encephalopathy, refractory ascites or gastric esophageal varices;
• There are contraindications to TACE treatment, such as portosystemic shunt, liver flow ablation, significant atherosclerosis;
• Hypersensitivity to intravenous contrast agents;
• Pregnant or lactating women or subjects with family planning within two years;
• With HIV, syphilis infection;
• Accompanied by other malignant tumors or suffering from other malignancies within 5 years before enrollment;
• Allogeneic organ transplant recipients;
• Severe dysfunction of heart and kidney or other organs;
• Active severe infection > grade 2 (NCI-CTC version 5);
• Suffering from mental and psychological diseases may affect informed consent;
• Unable to take oral medication;
• Participated in other drug clinical trials within 12 months before enrollment;
• Active gastric or duodenal ulcers within 3 months before enrollment.