SBRT Plus Lenvatinib and TACE for Advanced Primary HCC: A Phase 3 Trial (SEARCH) (SEARCH)
Advanced Hepatocellular Carcinoma
About this trial
This is an interventional treatment trial for Advanced Hepatocellular Carcinoma focused on measuring SBRT, TACE, Lenvatinib
Eligibility Criteria
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.
Sites / Locations
- The First Affiliated Hospital of Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
SBRT+TACE+Lenvatinib
Lenvatinib
Patients in SBRT+TACE+Lenvatinib group will take oral lenvatinib within 3 days of randomization and receive TACE 1 day after oral administration of lenvatinib. SBRT will begin within 3 weeks after the first TACE.
Patients in Lenvatinib group will take oral lenvatinib alone.