TACE-refractory HCC
Conditions
Interventions
LEN+SIRT:Lenvatinib plus SIRT
LEN:Lenvatinib
Sponsors
Second Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed or clinically diagnosed with hepatocellular carcinoma; 2. Determined to be TACE resistant according to the Japanese Society of Hepatology's 2021 liver cancer guideline criteria; 3. Recurrent tumors after surgical resection or ablation can be enrolled; 4. At least one measurable intrahepatic target lesion; 5. Liver function Child-Pugh A/B7; 6. Eastern Cooperative Oncology Group performance status (ECOG PS) score =50×10^9/L, white blood cell count > 3.0×10^9/L, absolute neutrophil >1.5×10^9/L, hemoglobin >=85 g/L, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =28g/L, total bilirubin 3 months; 11. Age 18~75 years old; 12. Both male and female.
Exclusion criteria
Exclusion criteria: 1.Tumor extent >=70% liver occupation; 2.Extrahepatic metastasis; 3.Tumor thrombus involving main portal vein or both the first left and right branches of portal vein; 4.Vena cava invasion; 5.Patients who received prior hepatic arterial infusion chemotherapy (HAIC), radiotherapy, or systemic therapy, for HCC; 6.History of organ and cell transplantation; 7.History of esophageal or gastric variceal bleeding; 8.History of hepatic encephalopathy; 9.History of other malignancies; 10.Human immunodeficiency virus infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR);Progression free survival (PFS);Time to response (TTR);Duration of response (DOR);Overall survival (OS);Adverse Events (AEs); | — |
Countries
China
Contacts
Public ContactCai Mingyue
Second Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed