Lenvatinib Plus SIRT vs Lenvatinib in TACE-Refractory HCC

Phase 2

Recruiting

• Conditions: Hepatocellular Carcinoma Non-resectable
• Interventions: Combination Product: Lenvatinib plus SIRT; Drug: Lenvatinib

• Registration Number: NCT06904196
• Lead Sponsor: Second Affiliated Hospital of Guangzhou Medical University

Brief 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).

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-25
• Study First Submitted QC: 2025-03-25
• Study Start: 2025-04-01
• Study First Posted: 2025-04-01
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29
• Primary Completion: 2028-03-31
• Study Completion: 2029-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Len+SIRT	Lenvatinib plus SIRT	Lenvatinib plus SIRT
LEN	Lenvatinib	Lenvatinib alone

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	3 years	The percentage of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR) according to mRECIST

Secondary Outcome Measures

Name	Time	Method
Duration of response (DOR)	3 years.	Time from first tumor response to first disease progression (mRECIST) or death from any cause (whichever occurs first)
Disease control rate (DCR)	3 years	The percentage of patients who had a tumor response rating of CR, PR, or stable disease (SD) according to mRECIST.
Progression free survival (PFS)	3 years	The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.
Time to response (TTR)	3 years	The time from treatment initiation to first tumour remission (mRECIST)
Overall survival (OS)	4 years.	The time from date of treatment initiation to death due to any cause
Adverse Events (AEs)	3 years.	Number of patients with AEs assessed by NCI CTCAE v5.0.

Trial Locations

Locations (1)

The Second Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China