Combination of SBRT and Immunotherapy in Small Hepatocellular Carcinoma (HSBRT2402)
Status:
RECRUITING
Trial end date:
2030-04-30
Target enrollment:
Participant gender:
Summary
For inoperable small hepatocellular carcinoma (HCC), stereotactic body radiotherapy (SBRT) is an effective and safe local treatment. Despite satisfactory local control rate, the incidence of recurrence out the field remains substantial, with 2-year PFS of 31.9% to 60.9%. Therefore, a more effective treatment mode is urgently needed. Immune checkpoint inhibitors targeting PD-1/PD-L1 have shown substantial clinical benefits in advanced HCC as well as resected high-risk HCC. Recently, the combination of immunotherapy with SBRT has shown promising activity in HCC, but its utility in small HCC is unclear. The aim of this study was to investigate the efficacy and safety of SBRT followed by sintilimab (an anti-PD-1 antibody) in patients with recurrent or residual small HCC.
Phase:
PHASE2
Details
Lead Sponsor:
Sun Yat-sen University
Collaborators:
Fifth Affiliated Hospital, Sun Yat-Sen University Ningbo Medical Center Lihuili Eastern Hospital