Abstract 214P
Background
Previous report has highlighted the promising anti-tumor activity of HAIC in combination with Sintilimab (sin) and Bevacizumab biosimilar (bev). Updated results for the entire sample population and a subset analysis on HCC patients (pts) with portal vein tumor thrombosis (PVTT) were reported herein.
Methods
Eligible untreated unresectable HCC pts with BCLC stage B or C were enrolled to receive sin (200 mg) and bev (15 mg/kg) IV on D1 Q3W, alongside FOLFOX-HAIC every 3-6 weeks. Pts underwent at least two examinations and were evaluated by MDT to decide whether perform hepatectomy or to continue the combination regimen. Sin and bev continued until PD, unacceptable toxicity, or up to 24 months. The primary endpoint was PFS per RECIST v1.1. The secondary endpoints included ORR, DCR, surgical conversion rate, pathologic response, OS, and safety.
Results
At data cutoff on Mar. 29, 2024, a total of 51 pts were enrolled with a median age of 54 years. 43 (84.3%) pts were at BCLC stage C, 47 (92.2%) pts had HBV infection, 39 (76.5%) had PVTT, and 9 (17.6%) exhibited extrahepatic spread. Among 50 tumor response evaluable pts, the ORR was 74% (37, all PR) and the DCR was 100% (RECIST v1.1), while according to mRECIST, ORR and DCR was 84% (42, 13 CR+29PR) and 100%, respectively. With a median follow-up of 13.1 months, the median PFS and OS were not reached; 12-m PFS rate and OS rate were 57.7% and 83.7%, respectively. Pts with Vp4 PVTT had a median PFS of 9.07 months (95% CI, 6.11-NA); median OS was not available. Surgical conversion rate was 22% (11), including one who exhibited Vp4, each of whom received no more than 2 courses of HAIC and median of 4 (1-10) cycles of systemic therapy before surgery. All pts achieved R0 resection. 6 pts (54.5%) experienced MPR of which 2 (18.2%) achieved pCR. No postoperative mortality was observed. The incidence of grade 3 TRAEs was 14%. No new safety signals were identified.
Conclusions
Considering the promising surgical conversion rate and acceptable safety profile, HAIC combined with sintilimab and bevacizumab could potentially serve as conversion therapy for initially unresectable HCC. Additionally, this therapeutic strategy might be a viable option for HCC pts with Vp4 PVTT.
Clinical trial identification
ChiCTR2300068116.
Editorial acknowledgement
Legal entity responsible for the study
Shanghai Eastern Hepatobiliary Surgery Hospital.
Funding
This work was supported by grants from the Natural Science Foundation of China (No. 82172880) and the Fund of Education Key Laboratory on Signaling Regulation and Targeting Therapy of Liver Cancer, Eastern Hepatobiliary Surgery Hospital/National Center for Liver Cancer (No. 2022-MEKLLC-MS-004).
Disclosure
All authors have declared no conflicts of interest.