NCT06904196

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Second Affiliated Hospital of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a prospective, non-randomized controlled trial to evaluate the efficacy and safety of LEN+SIRT versus LEN alone for patients with TACE-refractory HCC. 78 patients (39 in each arm) with TACE-refractory HCC will be enrolled in this study. The patients will receive either LEN+SIRT or LEN. Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight \< 60 kg, 8mg P.O. QD) will be administered to the patients and last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. For patients in the LEN+SIRT arm, lenvatinib will be started at 3-7 days after SIRT. The primary end point of this study is objective response rate (ORR). The secondary endpoints are disease control rate (DCR), progression-free survival (PFS), time to response (TTR), duration of response (DOR), overall survival (OS), and adverse events (AEs).

Conditions

• Hepatocellular Carcinoma Non-resectable

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Lenvatinib plus SIRT	Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. QD will be started at 3-7 days after the first SIRT.
DRUG	Lenvatinib	Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. QD.

Timeline

• Start date: 2025-04-01
• Primary completion: 2028-03-31
• Completion: 2029-03-31
• First posted: 2025-04-01
• Last updated: 2025-04-29

Locations

1 site across 1 country: China