Abstract 174P
Background
Transcatheter arterial chemoembolization (TACE) in combination with ablation has been used in treatment of unresectable hepatocellular carcinoma (HCC) so as to increase the local control. However, the long-term benefit is limited due to local and distant disease progression. We proposed the study of TACE in combination with ablation and durvalumab to explore the benefit of improving the efficacy and safety in unresectable HCC patients.
Methods
The study is an open-label pilot study designed to investigate the safety and efficacy of TACE in combination with ablation and durvalumab in histologically or radiologically confirmed HCC patients unsuitable for hepatectomy. After TACE treatment, patients receive ablation and durvalumab followed by durvalumab monotherapy until disease progression or death for up to 1 year. Tumor assessment are performed by mRECIST criteria by radiologists. The primary endpoint is adverse events of special interest (AESIs). The secondary endpoints are adverse events (AEs), progression-free survival (PFS), Time to progress and overall survival.
Results
The study is ongoing and the interim analysis was conducted. Fifteen patients were enrolled and received at least once TACE as of data cutoff date of 10 Nov 2023. There were 11 patients who received TACE plus ablation and at least 1 cycle of durvalumab, with 5 patients receiving 6 or more cycles of durvalumab. Of the 15 patients, 5 (33.3%) patients reported AESIs, including increased aspartate aminotransferase and increased alanine aminotransferase with grade 3 of 20.0% (3/15) and 13.3%(2/15), respectively. There were no grade 4 AEs or AE-related death. Serious AEs were reported in 20.0% (3/15) but were not treatment related. There were no durvalumab discontinuation due to treatment-related AEs (TRAEs). The median follow-up was 11.0 (range, 4.0-24.3) months. The median PFS is not yet statistically analyzed with 5 PFS events occurred by the date of cut-off.
Conclusions
TACE in combination with ablation and durvalumab therapy showed the acceptable safety with no unexpected adverse events in this interim analysis of the study. The study is ongoing and efficacy will be evaluated with more follow-up.
Clinical trial identification
NCT04517227.
Legal entity responsible for the study
The authors.
Funding
AstraZeneca.
Disclosure
Z. Ren: Non-Financial Interests, Personal, Research Grant: AstraZeneca; Non-Financial Interests, Personal, Advisory Role: Roach, MSD, AstraZeneca, GSK, CStone. All other authors have declared no conflicts of interest.