1002P - Efficacy and safety of tislelizumab combined with TKIs and FOLFOX4-HAIC in conversion therapy of unresectable hepatocellular carcinoma

Background

TKIs,ICIs and FOLFOX-HAlC has shown high conversion success rates in unresectable hepatocellular carcinoma(uHCC) patients. This study aimed to evaluate the efficacy and safety of tislelizumab combined with TKIs and FOLFOX4-HAlC as first-line conversion therapy in this population.

Methods

Between April, 2021, and March, 2023, we retrospectively analyzed clinical data of patients with uHCC who underwent tislelizumab ,TKIs(Lenvatinib, Donafenib) and FOLFOX4-HAIC. The primary outcome included ORR, DCR, conversion resection rate (CRR) and TRAEs. Data were expressed as median (range).

Results

A total of 31 patients (27 male, 4 female) completed conversion therapy assessment until the last follow-up time (April 27, 2023). Lenvatinib was administered in 23 patients and donafinib in 8 patients. The patients were characterized with a median age of 54.2 years (34-75), 6 patient with BCLC stage B, 24 patients with BCLC stage C, and 1 patient with HCC postoperative recurrence with intrahepatic metastasis. According to mRECIST criteria, tumor shrinkage was observed in 30 patients, with an ORR of 93.5% (29/31, including 61.3%[19/31] complete response), DCR of 96.8%(30/31), and median time to response(mTTR) of 1.35months (0.7-3.0). Successful conversion was observed in 24 (77.4%) of 31 patients per mRECIST. As of cut-off date, the actual CRR and pathological complete response(pCR) were 29.0%(9/31)and 66.7% (6/9), respectively. There was no operative death, and 1 recurrence after operation. With a median follow-up time of 16.2 months, median progression-free survival(PFS) and overall survival(OS) were not reached. During the follow-up period, 9 patients developed disease progression with a median time to progression(mTTP) of 6.3 months (1-17.8), of whom 5 died due to disease progression. Most common TRAE was aspartate aminotransferase(AST) increased (26 patients, 83.8%).Grades 3 TRAEs occurred in 19 patients (61.3%). All TRAES were tolerable and manageable.

Conclusions

Tislelizumab combined with TKIs and FOLFOX4-HAIC showed high conversion rate and acceptable toxicity in the treatment of uHCC, suggesting that this combination could be considered as a new conversion strategy in this population.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Xilin Du.

Funding

Natural Science Basic Research Program of Shaanxi.

Disclosure

All authors have declared no conflicts of interest.