Camrelizumab in combination with TACE for the treatment of unresectable hepatocellular carcinoma (HCC): A multicenter, single-arm, prospective real-world study.

e16114 Background: Transcatheter arterial chemoembolization (TACE) is considered to be the first-line topical therapy for unresectable hepatocellular carcinoma (HCC). However, the long-term efficacy of single TACE treatment is poor, with a five-year survival rate of 8%-43%. This study aims to investigate the efficacy and safety of TACE combined with camrelizumab in the treatment of unresectable HCC. Methods: This is a single-arm, prospective real-word study conducted in 14 hospitals in Jiangsu, China. Patients diagnosed with HCC received Camrelizumab (200mg, i.v. Q2W or Q3W) with or without antiangiogenic therapy (apatinib, lenvatinib, sorafenib, or regorafenib) at any stage of the TACE treatment. The primary endpoint was progression-free survival (PFS). Secondary endpoints were overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety. Kaplan-Meier method was used for survival analysis. This study was registered with ChiCTR.org.cn, number ChiCTR1900026163. Results: From September 2019 to January 2021, 151 patients were enrolled, of whom most were males and younger than 65 years, 92 (60.93%) had extrahepatic metastasis and 120 (79.47%) suffered from HBV infection, 59 (39.07%) had an AFP concentration of 400 ng/mL or higher, 150 (99.34) had an ECOG PS of 0 or 1, a Child-Puph score of A or B, and were classified as BCLC Stage B or C. In addition to TACE, 52 patients received camrelizumab alone, while the others also received antiangiogenic therapy. Most (139, 92.06%) of the patients received camrelizumab 200mg every 3 weeks. Of the 112 patients who were available for efficacy evaluation, 4 patients achieved CR, 25 achieved PR, and 53 achieved SD, resulting in an ORR of 25.89% and DCR of 73.21%. The median PFS was 4.27 months (95% CI, 3.45 to 7.36 months) and the median OS was 14.0 months (95% CI, 10.6 to NE months). The safety data were obtained from 140 patients. Treatment-related adverse events (TRAEs) occurred in 130 (92.86%) patients, with the commonest types including increased alanine and aspartate aminotransferases (65%), thrombocytopenia (57.86%), hypoalbuminemia (54.29%), hyperbilirubinemia (48.57%), anemia (42.86%), leukopenia (42.14%), neutropenia (37.14%) and proteinuria (20.71%). Severe AEs occurred in 52 (37.14%) patients, with the commonest types including thrombocytopenia (17.14%), increased alanine and aspartate aminotransferases (13.57%), neutropenia (8.57%) and hyperbilirubinemia (7.14%). Conclusions: The treatment strategy of TACE in combination with camrelizumab with or without antiangiogenic therapy showed encouraging clinical efficacy and manageable toxicity profile in treating unresectable HCC, which provided a new treatment option for HCC. Clinical trial information: ChiCTR1900026163.