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

Sun Yat-sen University

Status: Enrolling

Conditions: Ablation; Local Therapy; Recurrent Hepatocellular Carcinoma; Lenvatinib; Systemic Therapy

Treatments: Procedure: Ablation; Drug: Lenvatinb; Procedure: TACE

Study type: Interventional

Funder types: Other

Identifiers

NCT06609850

Liver Projiect 10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18-75 years;
2. RHCC diagnosed by imaging;
3. intermediate-stage RHCC (two to three lesions which at least one was >3 cm in size or more than three tumors);
4. the tumor number was no more than six, and the maximum tumor diameter was ≤5 cm;
5. absence of extrahepatic metastasis or macrovascular invasion;
6. Child-Pugh class A or B;
7. TACE as initial treatment after tumor recurrence and showed no tumor progression after TACE.
8. life expectance >3 months;

Exclusion criteria

1. under 18 years or over 75 years of age;
2. primary intermediate-stage HCC;
3. RHCC with more than six tumors, or single RHCC

(5) RHCC >5cm; (6) extrahepatic metastasis; (7) macrovascular tumor thrombus;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

TACE plus Lenvatinib

Active Comparator group

Description:

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. Lenvatinb (12 mg (body weight ≥60 kg) , 8 mg (body weight \<60 kg) orally once a day )

Treatment:

Procedure: TACE

Drug: Lenvatinb

TACE plus Lenvatinib and ablation

Experimental group

Description:

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. Lenvatinb (12 mg (body weight ≥60 kg) , 8 mg (body weight \<60 kg) orally once a day ) 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.

Treatment:

Procedure: TACE

Drug: Lenvatinb

Procedure: Ablation