Lenvatinib Plus SIRT vs Lenvatinib in TACE-Refractory HCC

Launched by SECOND AFFILIATED HOSPITAL OF GUANGZHOU MEDICAL UNIVERSITY · Mar 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the combination of two treatments—lenvatinib plus selective internal radiation therapy (SIRT)—to see if they work better together for patients with a type of liver cancer called hepatocellular carcinoma (HCC) who have not responded to another treatment called transarterial chemoembolization (TACE). The goal is to find out if this combination can help control the cancer more effectively than lenvatinib alone.

To be eligible for the trial, patients need to have confirmed or clinically diagnosed HCC that hasn't responded to TACE. They should also have at least one measurable tumor in the liver and a good overall health status. This means they should not have severe liver problems or other serious health conditions that could interfere with the trial. Participants will have regular check-ups and tests to monitor their health and how the treatment is working. It's important to note that this trial is not yet recruiting, so patients will need to wait until it starts to see if they can participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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