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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 18-75 years;

• RHCC diagnosed by imaging;

• intermediate-stage RHCC (two to three lesions which at least one was \>3 cm in size or more than three tumors);

• the tumor number was no more than six, and the maximum tumor diameter was ≤5 cm;

• absence of extrahepatic metastasis or macrovascular invasion;

• Child-Pugh class A or B;

• TACE as initial treatment after tumor recurrence and showed no tumor progression after TACE.

• life expectance \>3 months;

Locations
Other Locations
China
Chinese PLA General hospital
RECRUITING
Beijing
Contact Information
Primary
Qunfang Zhou
zhouqun988509@163.com
86 19868000115
Backup
Feng Duan
duanfeng@vip.sina.com
86 13910984586
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2028-10-30
Participants
Target number of participants: 116
Treatments
Active_comparator: TACE plus Lenvatinib
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 )
Experimental: TACE plus Lenvatinib and ablation
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.
Related Therapeutic Areas
Sponsors
Collaborators: Chinese PLA General Hospital
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov