Lenvatinib Plus SIRT vs Lenvatinib in TACE-Refractory HCC
Lenvatinib Combined With Yttrium-90 Selective Internal Radiation Therapy (SIRT) Versus Lenvatinib Alone in TACE-Refractory Hepatocellular Carcinoma: A Prospective Non-Randomized Controlled Study
Second Affiliated Hospital of Guangzhou Medical University
78 participants
Apr 1, 2025
INTERVENTIONAL
Conditions
Summary
This study is conducted to evaluate the efficacy and safety of lenvatinib plus SIRT (LEN+SIRT) compared with lenvatinib (LEN) alone for patients with hepatocellular carcinoma (HCC) refractory to transarterial chemoembolization (TACE).
Eligibility
Inclusion Criteria10
- Pathologically confirmed or clinically diagnosed HCC
- Diagnosis of HCC with TACE refractoriness according to the criteria proposed by Japan Society of Hepatology (2021)
- Patients who have Tumor recurrence after surgical resection or ablation are allowed to be included
- At least one measurable intrahepatic target lesion
- Child-Pugh class A/B
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Tumor extent \<70% liver occupation
- Candidates for SIRT must be confirmed suitable for SIRT after evaluation (including SPECT/CT evaluation after arterial perfusion with 99Tc-MAA)
- Adequate organ and hematologic function with platelet count ≥50×10\^9/L, leukocyte \>3.0×10\^9/L, Neutrophil count ≥1.5×10\^9/L, haemoglobin ≥85 g/L, ALT and AST≤5×ULN, albumin ≥28 g/L, total bilirubin ≤3× ULN, creatinine≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds
- Life expectancy of at least 3 months
Exclusion Criteria9
- Extrahepatic metastasis
- Tumor thrombus involving main portal vein or both the first left and right branches of portal vein
- Vena cava invasion
- Patients who received prior hepatic arterial infusion chemotherapy (HAIC), radiotherapy, or systemic therapy, for HCC
- History of organ and cell transplantation
- History of esophageal or gastric variceal bleeding
- History of hepatic encephalopathy
- History of other malignancies
- Human immunodeficiency virus infection
Interventions
Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. QD will be started at 3-7 days after the first SIRT.
Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. QD.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06904196