TACE With Lenvatinib Versus Lenvatinib Alone in in First-line Treatment of Advanced HCC

Study Overview
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Brief Summary
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This trial is is an open label, multicenter, randomized controlled phase 3 clinical trial. The purpose is to compare the efficacy and safety of lenvatinib plus TACE with lenvatinib alone for advanced HCC patients.

Official Title
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Transarterial Chemoembolization With Lenvatinib Versus Lenvatinib Alone in First-line Treatment of Advanced Hepatocellular Carcinoma: a Phase III, Multicenter, Randomized Controlled Trial

Conditions
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Advanced Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: TACE
* Drug: Lenvatinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-75 years old; Patients with primary advanced HCC (in accordance with AASLD2018 guidelines for the diagnosis of HCC), without any previous treatment; There is at least one measurable lesion in the liver according to mRECIST criteria, single tumor ≤ 10.0 cm or multiple tumors and tumor burden ≤50% , with portal vein tumor embolus or with extrahepatic metastasis; ECOG score 0-1; Child-Pugh class A; Expected survival time ≥ 3 months; Blood, liver and kidney function meet the following conditions: Neutrophil count ≥ 1.5 × 10 9 /L; Platelet count ≥ 60 × 10 9 /L; Hemoglobin ≥ 90 g/L; Serum albumin ≥ 30 g/L; Bilirubin ≤ 50 umol/L; AST, ALT ≤ 5 times the upper limit of normal, ALP ≤ 4 times the upper limit of normal; Prolongation of prothrombin time not to exceed the upper limit of normal by 6 seconds; Creatinine ≤ 1.5 times the upper limit of normal Exclusion Criteria: Preoperative imaging examination revealed diffuse intrahepatic lesions or invasion, inferior vena cava or primary branch bile duct; Previous history of hepatic encephalopathy, refractory ascites or gastric esophageal varices; There are contraindications to TACE treatment, such as portosystemic shunt, liver flow ablation, significant atherosclerosis; Brain metastases; Hypersensitivity to intravenous contrast agents; Pregnant or lactating women or subjects with family planning within two years; With HIV, syphilis infection; Accompanied by other malignant tumors or suffering from other malignancies within 5 years before enrollment; Allogeneic organ transplant recipients; Severe dysfunction of heart and kidney or other organs; Active severe infection > grade 2 (NCI-CTC version 4); Suffering from mental and psychological diseases may affect informed consent; Unable to take oral medication; Participated in other drug clinical trials within 12 months before enrollment;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lenvatinib + TACE<br>Patients in Lenvatinib + TACE group will take oral lenvatinib within 3 days of randomization and receive TACE 1 day after oral administration of lenvatinib. | Procedure: TACE<br>* TACE will be performed one day after oral administration of lenvatinib. TACE with either cTACE or DEB-TACE can be used, depending on the condition of each center.<br>Drug: Lenvatinib<br>* Lenvatinib will be taken within 3 days of randomization (dose: 8 mg qd for patients <60kg, and 12 mg qd for patients >60kg)<br>|
| Active Comparator: Lenvatinib<br>Lenvatinib alone | Drug: Lenvatinib<br>* Lenvatinib will be taken within 3 days of randomization (dose: 8 mg qd for patients <60kg, and 12 mg qd for patients >60kg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Defined as the time from randomization to death for any cause. | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression | Defined as the time from randomization to disease progression. | two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lenvatinib, Transarterial chemoembolisation