976P - Tislelizumab plus donafenib combined with transarterial chemoembolization in patients with resected high-risk hepatocellular carcinoma (TIDE): A prospective, single-arm, phase II trial

Background

Despite advances in treatment, there is no established standard adjuvant therapy for patients at high risk of hepatocellular carcinoma (HCC) recurrence post-curative-intent resection. This study was conducted to assess the efficacy and safety of adjuvant tislelizumab plus donafenib with transarterial chemoembolization (TACE) in high-risk HCC patients.

Methods

In this prospective, single-arm, phase Ⅱ study, HCC patients who underwent curative resection and had a single tumor larger than 5 cm in diameter with microvascular invasion (MVI) were recruited. Eligible patients underwent one cycle of TACE a month after surgery. Subsequently, within a week following TACE, they began treatment with tislelizumab (200 mg intravenously every 3 weeks) and donafenib (100 mg orally twice daily). This regimen was maintained for one year, unless interrupted by disease recurrence or intolerable toxicity. The primary endpoint was the cumulative 3-year recurrence-free survival (RFS) rate, while the secondary endpoints were overall survival (OS) and the incidence of adverse events.

Results

A total of 30 patients were enrolled from December 9, 2022, to December 13, 2023. The median tumor size was 7.5cm, 90% had MVI type I, 63% were infected with HBV, and 43% had cirrhosis. As of April 11, 2024, the median duration of follow-up was 10.8 months. There were 1 instances of patient relapse, and 1 patient died due to a cerebral hemorrhage following a fall. The median RFS and OS time have not been reached. The 1-year RFS rate and OS rate were 92.3% (95% CI, 82.6%-100.0%) and 96.2% (95% CI, 89.0%-100.0%) respectively. The incidence of grade 3 TRAEs stood at 13.3%, including rash, hand-foot skin reactions, and immune-related pneumonia. One patient experienced grade 4 elevations in aspartate aminotransferase (AST) and alanine aminotransferase (ALT). No patients encountered grade 5 TRAEs.

Conclusions

These results align with earlier reports. The combination of tislelizumab plus donafenib and TACE appears to be a promising adjuvant therapy for patients with high-risk HCC. Furthermore, no significant safety concerns were observed.

Clinical trial identification

ChiCTR2200063003.

Editorial acknowledgement

Legal entity responsible for the study

W. Peng.

Funding

Sichuan Cancer Society.

Disclosure

All authors have declared no conflicts of interest.