982P - HILL: The efficacy and safety of hepatic arterial infusion chemotherapy with FOLFOX regimen combine lenvatinib and durvalumab in unresectable hepatocellular carcinoma: A prospective, phase II, single-armed, clinical trial

Background

Nowadays, although patients with unresectable hepatocellular carcinoma(uHCC) have more treatment options, the overall prognosis of patients is still unsatisfactory. This study aimed to investigate the efficacy and safety of hepatic arterial infusion chemotherapy with FOLFOX (FOLFOX-HAIC) combine lenvatinib and durvalumab for uHCC.

Methods

In this prospective, phase 2, single-armed, clinical trial, uHCC patients were treated with FOLFOX-HAIC, lenvatinib, and durvalumab as the initiative treatment. The primary endpoint was progression-free survival (PFS), the secondary endpoints were objective regression rate (ORR), disease control rate (DCR), overall survival (OS), and safety.

Results

Between August 2021 to September 2023, 40 patients with uHCC were included in the present study. The median follow-up period was 23.1 months (95% confidence interval [CI], 19.0-23.8), during which time 3 patients died and 12 patients experienced disease progression. The median PFS was 15.8 months (95% CI, 8.3-23.3). the 1- and 2-year OS rates were 97.5% and 94.0%. There were 9 patients achieved complete regression (CR) or pathological complete regression (pCR), and 21 patients achieved partial regression (PR) according to mRECIST criterial. The ORR was 75.0%. Together with the 8 patients who achieved stable disease (SD), the DCR of this cohort reached 95.0%. The median time to response (TTR) was 2.2 months (95% CI, 2.5-3.5). The median duration of response (DOR) was 10.4 months (95% CI, 8.3-13.8). There were 7 patients (17.5%) received subsequent conversion surgery and all of them achieved R0 resection, 3 of which showed pCR according pathological examination. Safety analysis showed this combination of treatments was quite safe, 34 (85.0%) patients had mild adverse events (AEs) (grade 0-2). The most common grade 3-4 AEs were elevated alanine aminotransferase and thrombocytopenia (both grade 3 in 2 patients, 5.0%).

Conclusions

This combination of FOLFOX-HAIC, lenvatinib and durvalumab has shown favorable efficacy and safety in uHCC patients. This still need to be further validated in phase 3 randomized controlled study.

Clinical trial identification

NCT04961918.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.