Abstract 207P
Background
Advanced hepatocellular carcinoma (HCC) remains a therapeutic challenge despite advances in systemic therapies. Hepatic arterial infusion chemotherapy (HAIC) stands out as a compelling locoregional treatment for the tumor. Meanwhile, sintilimab plus bevacizumab has been recommended in first-line therapy for advanced HCC given its approval in China. This phase II study aimed to evaluate the efficacy and safety of combining HAIC with sintilimab and bevacizumab in these pts.
Methods
Thirty-eight pts with advanced HCC were enrolled in our institution from November 2022 to March 2024. The pts received mFOLFOX6-HAIC combined with sintilimab and bevacizumab as the first-line treatment. The HAIC was performed on a 3-week cycle for 6 cycles. The sintilimab (200 mg) and bevacizumab (7.5 mg/kg) were intravenously administered every 3 weeks for a maximum of 24 months unless there was any evidence of disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS) per RECIST 1.1. The secondary endpoints included objective response rate (ORR), disease control rate (DCR), time to response (TTR), and duration of response (DOR) assessed by both RECIST 1.1 and mRECIST. Overall survival (OS) and safety were also evaluated.
Results
All 38 pts were evaluable for response and toxicity up to June 2024, with a median follow-up of 11.9 months (range: 3.1–19.4). The confirmed ORR was 60.5% per RECIST 1.1, and 65.8% per mRECIST with 10 complete response (26.3%). The DCR was 94.7% irrespective of the RECIST category. The median TTR was 1.8 months (95% CI: 1.7–2.0) and 1.7 months (95% CI: 1.7–1.8) by RECIST 1.1 and mRECIST, respectively. The median PFS, OS and DOR were not reached. All pts experienced treatment-related adverse events (TRAEs). TRAEs of grade ≥3 were evident in 26 pts (68.4%), with the predominant events being lymphocyte count decreased (34.2%) and neutrophil count decreased (18.4%). No cases of treatment-related death occurred.
Conclusions
The combination of mFOLFOX6-HAIC with sintilimab and bevacizumab exhibited an encouraging short-term efficacy for advanced HCC by improving the ORR and DCR, with acceptable toxicity. We will report more data in future. ClinicalTrials.gov ID: NCT05617430.
Clinical trial identification
NCT05617430, Release date: 2022-11-15.
Editorial acknowledgement
Legal entity responsible for the study
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.