Real-world analysis of effectiveness in unresectable hepatocellular carcinoma patients treated with camrelizumab-based regimens.

Abstract

e16204 Background: Hepatocellular carcinoma (HCC) is a leading cause of cancer-related mortality, with limited therapeutic options for advanced stages. Camrelizumab, a monoclonal antibody against PD-1, has shown promise in the treatment of unresectable HCC both as monotherapy and in combination with anti-angiogenic tyrosine-kinase inhibitors (TKIs). Real-world data are crucial to assess the performance of camrelizumab-based regimens in routine clinical settings. This study aimed to evaluate the real-world therapeutic outcomes of camrelizumab-based regimens for unresectable HCC. Methods: This multi-center, real-world study included HCC patients diagnosed via pathology or imaging. These participants had been previously treated with camrelizumab-based regimens including camrelizumab monotherapy or combinations with TKIs, chemotherapy, locoregional treatments or other physician-recommended options. Observational data were collected including baseline characteristics, treatment regimens, efficacy and adverse events. The real-world best overall tumor response (rwBOR) was defined as the best results from multiple effectiveness evaluations, reflected in the real-world objective response rate (rwORR) and real-world disease control rate (rwDCR). Results: As of January 3, 2025, 1278 patients treated with camrelizumab-based regimen were evaluable for retrospective analysis. The median age was 57 years (range 19-85) with 28.7% aged ≥ 65 years, and the majority was male (86.9%). The baseline disease stages included 43.9% at China Liver Cancer Staging (CNLC) Ib-IIb, 23.2% at CNLC IIIa, and 32.9% at CNLC IIIb. Elevated AFP level (≥ 400 ng/mL) were observed in 37.9% of patients and 66.4% had Albumin-Bilirubin (ALBI) grade 2 or 3. Moreover, 28.4% had prior anti-tumor treatments. During the follow-up period, rwBOR revealed a rwORR of 29.1% (95% CI: 26.6–31.7) and a rwDCR of 90.8% (95% CI: 89.1–92.3). AFP level decreased as early as the first visit with a mean reduction of –1210.9 ng/mL (±19,697.0). ALBI scores declined from baseline and the proportion of patients with ALBI grade 1 maintained stable at approximately 30.0% throughout the follow-up. Conclusions: Camrelizumab-based regimens exhibited encouraging real-world effectiveness in unresectable HCC patients, achieving enhanced control of tumor progression while preserving liver function throughout the treatment. These findings provide valuable insights into the use of camrelizumab in routine clinical practice and highlight its potential as a foundational therapy for unresectable HCC within real-world patient populations.