Abstract 223P
Background
More than 70% of HCC patients are ineligible for radical resection at initial diagnosis while conversion therapy offers these patients a second chance to undergo surgery. However, no standard treatment recommendation for the conversion therapy of initial unresectable HCC (uHCC). This trial aims to investigate the efficacy and safety of HAIC in combination with camrelizumab and apatinib as a conversion therapy for uHCC.
Methods
This is a prospective single arm phase II study. Pts with histologically diagnosed or clinically confirmed HCC and BCLC B-C/CNLC IIa-IIb (assessed by MDT as unsuitable for radical resection surgery) were included. The enrolled pts received Apatinib (250 mg, qd), camrelizumab (200 mg, q3w), and FOLFOX-HAIC (D3-4, q3w), and the surgical feasibility of pts was evaluated every 3 cycles. The main endpoint is conversion rate.
Results
From August 12, 2022 to March 15, 2024, a total of 20 eligible pts were included: the median age of the pts was 59 years old (range: 28-80 ), with 95% male, 90% Child-Pugh A, and 90% BCLC C. As of May 30, 2024, the follow-up period was 3.5-20 months, with a median HAIC frequency of 3 (range, 1-6). Based on RECIST 1.1, the ORR of 16 assessable pts was 56.25% (95% CI, 33.18% -76.9%), of which 1 pt (6.25%) had complete response (CR) and 8 pts (50.0%) had partial response (PR). The disease control rate (DCR) is 100%. Among the 16 pts, the conversion rate was 62.5% (10/16), of which 7 underwent liver resection and all (100%) underwent R0 resection, 1 achieved clinical CR and abandoned surgery, 2 pts voluntarily abandoned surgery; Regarding pathological response,1 achieved pCR (14.29%), and 2 (28.57%) achieved major pathological remission (MPR). The mPFS and mOS were not obtained. The grade 3-4 treatment-related adverse events (TRAEs) are liver dysfunction (20.0%), neutropenia (15.0%), hypertension (15.0%), thrombocytopenia (10.0%), anemia (5.0%), and hypokalemia (5.0%).
Conclusions
HAIC combined with camrelizumab and apatinib as conversion therapy for initial uHCC demonstrated a promising efficacy and manageable toxicity, thus might be an applicable strategy for conversion therapy of patients with uHCC.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.