980P - Hepatic artery infusion chemotherapy (HAIC) plus sintilimab and bevacizumab biosimilar (IBI305) for initial unresectable hepatocellular carcinoma (HCC) in patients with Child-Pugh B liver function: A prospective study

Background

Our previous study verified the safety and efficacy of combining sintilimab and bevacizumab biosimilar (IBI305) for treating HCC patients (pts) with Child-Pugh B liver function. This subset, comprising approximately 22.6% of cases in our department, lacks a standardized first-line treatment. Despite the limited guidance on integrating local treatments like HAIC for them, our findings reveal significant benefits from this combined regimen, even among patients typically excluded from clinical trials.

Methods

Eligible pts had histologically diagnosed or clinically confirmed HCC, with CNLC stage Ib-IIIb, no prior systemic treatment, Child-Pugh B, and ECOG 0 or 1. Pts received modified FOLOFOX-HAIC (oxaliplatin 65 mg/m², leucovorin 200 mg/m², fluorouracil bolus 200 mg/m², fluorouracil infusion 1200 mg/m², every 3 weeks), with intravenous Sintilimab (200 mg) and IBI305 (7.5 mg/kg), also every 3 weeks. Primary endpoints: safety, objective response rate (ORR) and disease control rate (DCR). Secondary endpoints: median overall survival (mOS) and median progression-free survival (mPFS).

Results

According to our initial efficacy evaluation (April 2021 to July 2023), data from 24 pts showed: median age 57, mostly male (87.5%), ECOG 0 (100%), Child-Pugh B (100%). CNLC staging: Ib (1), IIa (1), IIb (3), IIIa (12), IIIb (7). BCLC staging: B (5), C (19). HBV/HCV infection: 91.7%. AFP >400ng/ml: 58.3%, tumor diameter >10 cm: 54.2%. ORR: 29.2% (7 PR), DCR: 87.5% (7 PR, 14 SD). Surgical conversion rate: 16.7% (4/24), achieving R0 resection and no patients achieved pCR. Common TRAEs: anemia (4/24), platelet count decrease (14/24), white blood cell decrease (5/24), no grade 4+ TRAEs observed. The mOS and mPFS for these 24 pts were recently determined to be 13.55 months and 7.35 months, respectively.

Conclusions

The modified regimen of FOLOFOX-HAIC with Sintilimab and IBI305, especially with tailored chemotherapy and targeted therapy doses, shows promising safety and efficacy for patients with unresectable HCC and Child-Pugh B liver function. This emphasizes the necessity of incorporating this subgroup into broader clinical trials.

Clinical trial identification

NCT05616390.

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.