NCT06609850

The Comparison of TACE-Lenvatinib With TACE-Lenvatinib-ablation for Intermediate Recurrent Hepatocellular Carcinoma

The Comparison of TACE-Lenvatinib With TACE-Lenvatinib-ablation for Intermediate Recurrent Hepatocellular Carcinoma: a Multicenter Randomized Control Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Studies have shown that combination therapy of TACE with Lenvatinib could achieve better survival outcomes than TACE alone for hepatocellular carcinoma (HCC) at BCLC B stage. However, whether patients could benefit from the ablation for intermediate recurrent HCC (RHCC) is still need high quality clinical evidence. This study is to evaluate the efficacy of ablation combined with TACE and Lenvatinib for the intermediate-stage RHCC.

Detailed description

The evidence of ablation combined transarterial chemoembolisation (TACE) and Lenvatinib for intermediate-stage recurrent hepatocellular carcinoma (RHCC) is limited. Patient responses to this treatment vary because of the heterogeneous nature of RHCC. Thus, it is important to identify patients who are most likely to benefit from this three regimes therapy. The aim of this study is to comparison of TACE-Lenvatinib with TACE-Lenvatinib-ablation for intermediate RHCC.

Conditions

• Recurrent Hepatocellular Carcinoma
• Lenvatinib
• Local Therapy
• Ablation
• Systemic Therapy

Interventions

Type	Name	Description
PROCEDURE	TACE	TACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then a combination of lipiodol (5-15 ml), lobaplatin (30-50 mg), and Pirarubicin (30-50 mg) was infused into each tumor. We defined technical success as complete embolization of the tumor-feeding artery resulting in no tumor staining observed by angiogram at the end of procedure.
PROCEDURE	Ablation	Ablation (radiofrequency ablation, microwave ablation, cryoablation), ablation followed TACE within 6-8 weeks and Lenvatinib continued. Percutaneous ablation was performed by ultrasound or CT. The ablation success is evaluated by achieving an ablative margin of 0.5 cm or more than the tumor size.
DRUG	Lenvatinb	Lenvatinb (12 mg (body weight ≥60 kg) , 8 mg (body weight \<60 kg) orally once a day )

Timeline

• Start date: 2024-10-01
• Primary completion: 2026-10-01
• Completion: 2028-10-30
• First posted: 2024-09-24
• Last updated: 2024-12-03

Locations

1 site across 1 country: China