TACE Combined With Lenvatinib Versus TACE Sequential Lenvatinib in the Treatment of Intermediate/Advanced Liver Cancer

Hepatocellular Carcinoma Clinical Trial

Official title: Prospective, Randomized Controlled, Single-center, Phase III Clinical Study of TACE Combined With Lenvatinib Versus TACE Sequential Lenvatinib in the Treatment of Intermediate/Advanced Liver Cancer

Status Recruiting

Clinical Trial Summary

TACE(transcatheter arterial chemoembolization) has been recommended by domestic and international guidelines as the standard treatment for a subset of HCC patients with very high heterogeneity, including BCLC stage B(intermediate-stage) and some BCLC stage C(advanced-stage). However, for these patients, TACE therapy alone is often difficult to achieve satisfactory efficacy. Moreover, in the course of repeated TACE treatment, tumor remission rate continues to decrease, and drug resistance and liver function damage are prone to be aggravated.Studies have shown that TACE and TKI combined therapy can not only inhibit the release of VEGF and other angiogenic growth factors after TACE, but also prolong the interval of TACE treatment、reduce the frequency of TACE treatment by inhibiting residual tumor proliferation, thus reducing liver function damage.Lenvatinib therapy,which is associated with a high response rate compared with Sorafinib and the cost-effect advantage of Lenvatinib was significantly better than that of sorafenib.But it has not been determined whether lenvatinib should be used synchronously or sequentially based on TACE.Through the comparative study of different timing combinations, we explore the interventional timing of Lenvatinib in intermediate-advanced liver cancer, providing a new scheme for interventional combination therapy.

Clinical Trial Description

Femoral artery puncture and catheterization were performed in every cycle of treatment,a catheter was inserted and located in feeding hepatic artery of tumor. The therapeutic scheme was that, synchronous treatment group(experimental group): the first course of TACE treatment was started after 2-3 weeks Lenvatinib treatment.Sequential treatment group(control group): patients with uncontrolled TACE progression after TACE treatment were sequentially treated with Lenvatinib.TACE was repeated on demand and continued until disease progression or unacceptable toxicity.Follow-up was performed every 3 months after disease stabilization until disease progression. When tumor progression occurs, subjects should follow the second-line or third-line regimen recommended in the current clinical guidelines for the diagnosis and treatment of liver cancer. ;

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Liver Neoplasms

• NCT number: NCT05220020
• Study type: Interventional
• Source: Sun Yat-sen University
• Contact: Ming Zhao, M.D. & Ph.D.
• Phone: 86-20-87343272
• Email: zhaoming@sysucc.org.cn
• Status: Recruiting
• Phase: Phase 3
• Start date: May 18, 2022
• Completion date: February 28, 2025