Lenvatinib Plus SIRT vs Lenvatinib in TACE-Refractory HCC

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital of Guangzhou Medical University

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Lenvatinib plus SIRT
  • Lenvatinib

Treatment groups

78 Participants
are divided into 2 treatment groups