residual HCC after TACE
Conditions
Interventions
Test group:lenvatinib plus tislelizumab and SIRT
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 HCC (recurrent tumors after surgical resection or ablation are eligible); 2. Persistent viable tumor after >=2 consecutive TACE treatments, and assessed by the interventional team as unlikely to benefit from further TACE; 3. At least one measurable viable intrahepatic target lesion; 4. Child-Pugh class A or B7; 5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score =75×10^9 /L, White blood cell count >3.0×10^9 /L, Absolute neutrophil count >1.5×10^9 /L, Hemoglobin >=85 g/L, ALT and AST =28 g/L, Total bilirubin =100 IU/mL. Patients with chronic hepatitis C (HCV) infection are eligible but must have completed anti-HCV treatment before enrollment; 10. Life expectancy of at least 3 months; 11. Age range from 18 to 75 years old, both male and female are acceptable.
Exclusion criteria
Exclusion criteria: 1. Extrahepatic metastasis; 2. Bile duct or portal vein invasion beyond unilateral involvement (contralateral or main trunk involvement); 3. Inferior vena cava tumor thrombus; 4. Prior treatment with hepatic arterial infusion chemotherapy (HAIC), radiotherapy, or systemic therapy; 5. History of organ or cellular transplantation; 6. History of variceal bleeding; 7. History of hepatic encephalopathy; 8. History of other malignancies; 9. Co-infection with hepatitis B and hepatitis C virus; 10. HIV infection; 11. Autoimmune disease; 12. Requirement for long-term systemic corticosteroid therapy (daily dose equivalent to >10 mg prednisone) or any form of immunosuppressive therapy; 13. Pregnancy (or intent to become pregnant) or lactation;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) per mRECIST; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Progression free survival (PFS);Duration of response (DOR);ORR per RECIST 1.1;Adverse Events (AEs);Disease control rate (DCR); | — |
Countries
China
Contacts
Public ContactZhu Kangshun
Second Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed