TACE Plus Envafolimab, Lenvatinib Show Efficacy in Conversion of Unresectable HCC to Resectable Disease

While transcatheter arterial chemoembolization (TACE) is a commonly used first-line treatment for intermediate and advanced hepatocellular carcinoma, repeated use of TACE can impair liver function and stimulate tumor angiogenesis. Some patients who undergo TACE may also experience tumor recurrence. 

As adding an anti-angiogenic therapy to TACE can improve treatment effects over TACE monotherapy, a phase II trial has investigated the safety and efficacy of TACE with envafolimab and lenvtatinib for unresectable hepatocellular carcinoma (uHCC). 

Patients with uHCC were administered envafolimab and lenvatinib after undergoing TACE until disease progression, conversion to surgery, intolerable toxicities, or death. The primary endpoint was objective response rate (ORR). 

Thirty-eight patients were included in the study as part of the safety analysis and 36 were included for efficacy analysis. 

As of the data cutoff in December 2023, the median follow-up period was 16.9 months. Patient ORR was 50%, while the disease control rate (DCR) was 83.3% according to RECIST 1.1. The median progression-free survival (PFS) rate was 7.58 months. 

The surgical conversion rate was 47.2%, with 17 patients converted to resectable HCC. Sixteen patients who underwent surgery had an R0 resection rate of 100% with a pathologic complete response (pCR) rate of 31.3%. 

The overall occurrence of treatment-related adverse events (TRAEs) of any grade was 97.4%, with TRAEs of grade 3 or higher observed in 52.6% of patients. No treatment-related deaths occurred. 

In patients with uHCC, the use of the combined treatment of envafolimab plus lenvatinib with TACE resulted in promising survival outcomes and conversion efficiency by improving the immune status of the tumor microenvironment.