202P - Hepatic arterial infusion tislelizumab and chemotherapy plus DEB-TACE in combination with lenvatinib for first-line treatment of unresectable HCC: A prospective, single arm, phase II study (HAITC study)

Background

Immune checkpoint inhibitors (ICIs) plus anti-angiogenic therapy has shown promising efficacy for unresectable HCC with 20% - 30% tumor response. But there are still many patients with primary resistance to these regimens. Hepatic arterial administration is a potential approach to improve efficacy by enhancing local drug concentration. Tislelizumab is a PD-1 inhibitor with good drug availability in China, which has been approved for first-line treatment of advanced HCC. In this study, we explored the efficacy and safety of hepatic arterial infusion tislelizumab and chemotherapy plus DEB-TACE in combination with lenvatinib in unresectable HCC patients.

Methods

This is a prospective, single arm, phase II study. Key eligible criteria included pathologically and/or radiologically diagnosed as HCC of BCLC stage B/C, ECOG PS score of 0 or 1, Child-Pugh class A/B, no previous systemic antitumor therapy. Patients received DEB-TACE, lenvatinib (8mg for body weight <60kg and 12mg for body weight ≥60kg, po, qd) and hepatic arterial infusion tislelizumab (200mg, q3w) and mFOLFOX chemotherapy. The primary endpoint is ORR per RECIST v1.1.

Results

From May 2022 to Nov 2023, 20 pts were enrolled: median age 60.5 (range, 31-79), 85% male, 70% ECOG PS score of 1, 85% Child-Pugh class A, 55% BCLC stage C, 55% hepatitis B infection, 40% with AFP > 400ng/ml. All pts received at least 1 dose of tislelizumab. At the data cut-off (Jun 14^th,2024), the ORR was 50% (n=10) per RECIST v1.1 and 65% (n=13) per mRECIST. The DCR was 95% (n=19) per RECIST v1.1 or mRECIST. Median PFS and OS were not reached. Treatment related AEs of any grade occurred in 100% patients. The most common TRAEs (incidence ≥ 10%) included asthenia (100%) and liver dysfunction (10%). Only 1 (5%) pt reported Grade 3-4 TRAEs (AST/ALT elevated and hypoalbuminemia).

Conclusions

In this study, hepatic arterial infusion tislelizumab and chemotherapy plus DEB-TACE in combination with Lenvatinib showed potential efficacy and acceptable safety for first line treatment of unresectable HCC.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

BeiGene.

Disclosure

All authors have declared no conflicts of interest.