HAIC Plus Sintilimab, Bevacizumab Biosimilar for Patients With uHCC, Child-Pugh B Liver Function

A modified regimen of FOLFOX with hepatic artery infusion chemotherapy (FOLFOX-HAIC) plus sintilimab and IBI305—a bevacizumab biosimilar—demonstrates promising safety and efficacy in patients with unresectable hepatocellular carcinoma (uHCC) and Child-Pugh B liver function, according to research presented at the European Society for Medical Oncology Congress 2024.

Previous research suggests that combining sintilimab with IBI305 is safe and effective for patients with HCC and Child-Pugh B liver function. However, a standardized first-line treatment for these patients is lacking, and limited data exists on the integration of local treatments—like HAIC—into the management plan.

A group of researchers from China sampled 24 patients from April 2021 to July 2023 with histologically diagnosed or clinically confirmed HCC. Patients had stage Ib-IIIB disease, no prior systemic treatment, Child-Pugh B liver function, and an Eastern Cooperative Oncology Group SCORE OF 0 or 1. All patients received modified FOLOFOX-HAIC (oxaliplatin 65 mg/m², leucovorin 200 mg/m², fluorouracil bolus 200 mg/m², fluorouracil infusion 1200 mg/m²), along with intravenous sintilimab (200 mg) and IBI305 (7.5 mg/kg) every three weeks.

The primary endpoints of the study included safety, objective response rate (ORR), and disease control rate (DCR). Secondary endpoints included median overall survival (OS) and median progression-free survival (PFS).

The observed ORR was 29.2% with 7 patients achieving a partial response. The DCR was 87.5%, with 7 partial responses and 14 patients with stable disease.

Researchers noted that 16.7% (n=4) of patients achieved R0 after resection and none achieved pathologic complete response. Treatment-related adverse events (TRAEs) included anemia (n=24), platelet count decrease (n=14), and white blood cell decrease (n=5). No grade 4 or higher TRAEs were observed.

The median OS and PFS was 13.55 months and 7.35 months, respectively.

“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,” study authors concluded. “This emphasizes the necessity of incorporating this subgroup into broader clinical trials.”