BackgroundMost patients with hepatocellular carcinoma (HCC) are diagnosed at intermediate or advanced stages, when curative resection is not feasible. Conversion therapy aiming to downstage tumors and enable surgical resection has emerged as a potential strategy.
We performed an exploratory, single-arm pilot study to assess the efficacy and safety of transarterial chemoembolization (TACE) combined with lenvatinib and the envafolimab in this setting.MethodsThis single-center, open-label, single-arm pilot trial enrolled patients with Barcelona Clinic Liver Cancer stage B or C unresectable HCC between April and September 2024. Patients received conventional TACE combined with oral lenvatinib and subcutaneous envafolimab until surgical conversion, disease progression, unacceptable toxicity, or death.
The primary endpoint was the conversion rate to curative-intent resection. Secondary endpoints included objective response rate (ORR), disease control rate (DCR), pathological response, progression-free survival (PFS), overall survival (OS), and safety.ResultsFifteen patients were enrolled.
According to mRECIST criteria, the ORR was 53.3% and the DCR was 86.7%. Nine patients (60.0%) achieved sufficient tumor downstaging to undergo curative-intent surgery, and all achieved R0 resection.
Pathological complete or major response was observed in five resected patients (55.6%).
Frontiers in Immunology published a clinical update in Infectious Disease on 22 Apr 2026.
The item focuses on TACE plus lenvatinib and envafolimab for conversion therapy in unresectable HCC: a prospective pilot study.
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