Transarterial chemoembolization plus atezolizumab and bevacizumab in patients with intermediate hepatocellular carcinoma: a single-arm, phase 2 trial

Abstract Transarterial chemoembolization (TACE) is the standard treatment for intermediate-stage hepatocellular carcinoma (HCC), yet its efficacy as a standalone therapy remains suboptimal. This phase 2 trial (ChiCTR2100049829) evaluated the feasibility and safety of TACE combined with atezolizumab and bevacizumab in patients with intermediate-stage HCC. Participants received TACE followed by atezolizumab and bevacizumab until disease progression, unacceptable toxicity, or death. The primary endpoint was objective response rate (ORR) assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Secondary endpoints included progression-free survival (PFS), overall survival (OS), ORR by modified RECIST (mRECIST), disease control rate (DCR), time to response (TTR), duration of response (DOR), and adverse events (AEs). Between August 21, 2021 and April 10, 2023, 45 patients were enrolled. As of the data cutoff on September 30, 2024, the median follow-up was 26.7 months. The ORR was 47% per RECIST v1.1 and 67% per mRECIST. Median PFS was 17.9 months, and median OS was 33.0 months. The DCR was 87% (RECIST v1.1) and 91% (mRECIST). Median TTR was 11.9 weeks (RECIST v1.1) and 4.9 weeks (mRECIST), with median DOR of 36.6 weeks (RECIST v1.1) and 44.4 weeks (mRECIST). Of the 45 patients, 44 experienced AEs of any grade, with 20 reporting grade 3-4 AEs; no grade 5 AEs were observed. TACE combined with atezolizumab and bevacizumab appears safe and feasible for intermediate-stage HCC, supporting further investigation in larger studies.