Combination of Sintilimab and Stereotactic Body Radiotherapy in Hepatocellular Carcinoma (ISBRT01)
Status:
Recruiting
Trial end date:
2022-10-31
Target enrollment:
Participant gender:
Summary
Although sorafenib is the standard treatment for hepatocellular carcinoma with portal vein
invasion, the outcome of these patients remains very poor, with a median survival time of 5.5
to 7.2 months. It has been demonstrated that first-line treatment with transarterial
chemoembolization plus radiotherapy could provide more favorable survival than sorafenib
alone. However, intrahepatic dissemination and distant metastasis remains the major
recurrence pattern after treatment in these patients; therefore, searching for new strategies
to improve efficacy is necessary. Immunotherapy targeting the PD-1/PD-L1 checkpoints has
demonstrated promising activity in advanced HCC. Combining radiotherapy with immune
checkpoints showed promising response rates and improved survival in several solid tumor
types. The aim of this randomized study was to investigate the efficacy and safety of
stereotactic body radiotherapy followed by sintilimab (an anti-PD-1 antibody) compared with
stereotactic body radiotherapy alone for hepatocellular carcinoma with portal vein invasion
after arterially directed therapy.