Spots Global Cancer Trial Database for Combination of SBRT and Immunotherapy in Small Hepatocellular Carcinoma (HSBRT2402)

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Trial Identification

Brief Title: Combination of SBRT and Immunotherapy in Small Hepatocellular Carcinoma (HSBRT2402)

Official Title: Stereotactic Body Radiotherapy With or Without Adjuvant Immunotherapy for Small Hepatocellular Carcinoma: An Open-label, Randomized, Phase II Trial

Study ID: NCT06313190

Conditions

Hepatocellular Carcinoma

Interventions

Stereotactic body radiotherapy

Sintilimab

Study Description

Brief 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.

Detailed Description: A total of 140 patients with recurrent or residual small HCC will be stratified according to tumor diameter (≤3 vs. \>3 cm) and tumor type (recurrent vs. residual) and randomly assigned (1:1) to receive stereotactic body radiotherapy (SBRT) with or without adjuvant sintilimab for 6 cycles (200 mg, once every 3 weeks, with the first dose within 1 week after the completion of SBRT).