Camrelizumab (a PD-1 inhibitor) plus apatinib (an VEGFR-2 inhibitor) and hepatic artery infusion chemotherapy for hepatocellular carcinoma in Barcelona Clinic Liver Cancer stage C (TRIPLET): a phase Ⅱ study

Hepatic arterial infusion chemotherapy(HAIC)using a combination of oxaliplatin,fluorouracil,and leucovorin(FOLFOX)has shown promise for hepatocellular carcinoma(HCC)patients classified under Barcelona Clinic Liver Cancer(BCLC)stage C.In China,the combined therapy of camrelizumab and apatinib is now an approved first-line approach for inoperable HCC.This study(NCT04191889)evaluated the benefit of combining camrelizumab and apatinib with HAIC-FOLFOX for HCC patients in BCLC stage C.Eligible patients were given a maximum of six cycles of HAIC-FOLFOX,along with camrelizumab and apatinib,until either disease progression or intolerable toxicities emerged.The primary outcome measured was the objective response rate(ORR)based on the Response Evaluation Criteria in Solid Tumors(RECIST)v1.1.Thirty-five patients were enrolled.Based on RECIST v1.1 criteria,the confirmed ORR stood at 77.1%(95%CI:59.9%to 89.6%),with a disease control rate of 97.1%(95%CI:85.1%to 99.9%).The median progression-free survival was 10.38 months(95%CI:7.79 to 12.45).Patient quality of life had a transient deterioration within four cycles of treatment,and generally recovered thereafter.The most frequent grade≥3 or above treatment-related adverse events included reduced lymphocyte count(37.1%)and diminished neutrophil count(34.3%).The combination of camrelizumab,apatinib,and HAIC demonstrated encouraging results and manageable safety concerns for HCC at BCLC stage C.