TACE plus lenvatinib and envafolimab for conversion therapy in unresectable HCC: a prospective pilot study

Area of Science:

• Hepatobiliary Malignancies
• Interventional Oncology
• Translational Cancer Research

Background:

• Hepatocellular carcinoma (HCC) is often diagnosed at advanced stages, precluding curative resection.
• Conversion therapy aims to downstage tumors, making surgical resection feasible.
• This study explores a novel combination therapy for unresectable HCC.

Purpose of the Study:

• To assess the efficacy and safety of transarterial chemoembolization (TACE) combined with lenvatinib and envafolimab.
• To evaluate the conversion rate to curative-intent resection in patients with unresectable HCC.
• To determine the objective response rate (ORR), disease control rate (DCR), and survival outcomes.

Main Methods:

• A single-arm, open-label pilot trial involving 15 patients with Barcelona Clinic Liver Cancer stage B or C HCC.
• Patients received conventional TACE, oral lenvatinib, and subcutaneous envafolimab.
• Primary endpoint was the conversion rate to surgery; secondary endpoints included ORR, DCR, pathological response, PFS, OS, and safety.

Main Results:

• A 60.0% conversion rate to curative-intent surgery was achieved, with all patients undergoing R0 resection.
• The objective response rate (ORR) was 53.3% and the disease control rate (DCR) was 86.7%.
• Median progression-free survival (PFS) was 12.0 months, with a 1-year overall survival (OS) of 100%.

Conclusions:

• Combination therapy of TACE, lenvatinib, and envafolimab shows encouraging antitumor activity and a high conversion rate for unresectable HCC.
• The treatment was associated with an acceptable safety profile, but gastrointestinal bleeding is a notable concern.
• Larger, controlled trials are needed to validate these preliminary findings.