Abstract 717P
Background
In the treatment of advanced uHCC, combination therapy of antiangiogenic targeted drugs combined with immune checkpoint inhibitors has become a hot topic，but efficacy still does not meet clinical needs, and the objective response rate (ORR) is only 27%-36%. TACE is widely used in the treatment of advanced uHCC. The aim of this study was to evaluate the efficacy and safety of TACE in combination with TIS and LEN in patients with uHCC.
Methods
This study was single-center, single-arm, open-label phase II exploratory clinical study (NCT05131698). Eligible patients were BCLC-C and not candidates for surgical resection or liver transplantation, at least one lesion evaluable by RECIST 1.1 criteria, an Eastern Cooperative Oncology Group performance status of 0 or 1, and Child-pugh grade A. Enrolled patients received TACE treatment (loplatin + raltitrexed + iodine oil) at the beginning, and then were treated with TIS (200 mg, IV, on Day 1 of a 21-day cycle) and LEN (body weight ≥ 60 kg: 12 mg/day; < 60 kg: 8 mg/day) daily. The primary endpoint of this study was safety and ORR by RECISTv1.1. The secondary endpoints included overall survival (OS), disease control rate (DCR), and progression-free survival (PFS).
Results
As of March 18, 2022, a total of 18 patients were enrolled and had TIS in combination with LEN after TACE treatment. Patients had BCLC stage C, Child-Pugh scores of 5 (n = 8) or 6 (n = 10). The median follow-up time is 6.0 months. The overall ORR and DCR were 50% and 66.7%, respectively (1 CR, 5.5%; 8 PR, 44.5%; 3 SD, 16.7%). All 18 patients remained on study. Any grade treatment-emergent adverse events (TEAEs) occurred in 44.5% (n=8). The most common TEAEs were abnormal liver function (n=7, 38.8%), thrombocytopenia (n=5, 27.7%), and leukopenia (n=5, 27.7%). Only one patient experienced grade 3 TEAE (pneumonia); seven patients experienced grade 1 TEAEs.
Conclusions
Preliminary analysis showed that TACE combined with TIS and LEN showed a considerable efficiency with relatively high ORR and a tolerable safety profile in uHCC treatment.
Clinical trial identification
NCT05131698 release date: July 1, 2021.
Editorial acknowledgement
Legal entity responsible for the study
Guangxi Medical University Cancer Hospital.
Funding
BeiGene biopharma incorporation.
Disclosure
All authors have declared no conflicts of interest.