RECRUITINGINTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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; Who Should NOT Join This Trial: 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; Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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;

Treatments Being Tested

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 )

Locations (1)

Chinese PLA General hospital

Beijing, None Selected, China