Combination of SBRT and Immunotherapy in Small Hepatocellular Carcinoma (HSBRT2402) - Trial NCT06313190
Access comprehensive clinical trial information for NCT06313190 through Pure Global AI's free database. This Phase 2 trial is sponsored by Sun Yat-sen University and is currently Not yet recruiting. The study focuses on Hepatocellular Carcinoma. Target enrollment is 140 participants.
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Study Focus
Sponsor & Location
Sun Yat-sen University
Timeline & Enrollment
Phase 2
Apr 05, 2024
Apr 30, 2030
Primary Outcome
Progression-free survival (PFS) rate
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06313190
Non-Device Trial