Lenvatinib Plus SIRT vs Lenvatinib in TACE-Refractory HCC

Second Affiliated Hospital of Guangzhou Medical University

Status and phase: Enrolling; Phase 2

Conditions: Hepatocellular Carcinoma Non-resectable

Treatments: Combination Product: Lenvatinib plus SIRT; Drug: Lenvatinib

Study type: Interventional

Funder types: Other

Identifiers

NCT06904196

MIIR-21

Details and patient eligibility

About

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).

Full 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).

Enrollment: 78 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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78 participants in 2 patient groups

Len+SIRT

Experimental group

Description:

Lenvatinib plus SIRT

Treatment:

Combination Product: Lenvatinib plus SIRT

LEN

Active Comparator group

Description:

Lenvatinib alone

Treatment:

Drug: Lenvatinib