Testing Immunotherapy for Patients With Liver Cancer and Moderately Altered Liver Functions
Status:
Not yet recruiting
Trial end date:
2028-04-04
Target enrollment:
Participant gender:
Summary
Liver cancer is the third leading cause of cancer-related deaths worldwide. The majority of
primary liver cancers occur as hepatocellular carcinoma (HCC), the incidence of which is
increasing in many parts of the world. The vast majority of HCC cases occur in the setting of
liver cirrhosis, usually due to chronic viral infections with hepatitis C or hepatitis B,
alcohol consumption, non-alcoholic fatty liver disease or diabetes. The degree of underlying
liver disease, as well as the stage of the tumour and the general condition of the patients,
should therefore be taken into account when deciding on the treatment of HCC. Most patients
with HCC have advanced disease at the time of diagnosis, or have recurrent disease after
potentially curative treatments.
Tislelizumab showed enhanced cellular functional activities by blocking PD-1-mediated reverse
signal transduction and activating human T cells and primary peripheral blood mononuclear
cells in vitro.
Based on this preliminary safety profile, and knowing that there is antitumour activity, we
can offer tislelizumab as a single agent in patients with unresectable HCC.
HESTIA study is a multicentric French national phase II trial assessing tislelizumab in
monotherapy for patients with Hepatocellular Carcinoma Child-Pugh B and ALBI grade 1 or 2
liver function score.
It is planned to include 50 patients in the study. All patients will be recruited in France.
The study will be presented to eligible patients at participating centres and an information
note will be provided. No advertising material is planned for this study.
To be eligible, patients must meet all the following criteria to be ≥18 years old, with
histologically proven Hepatocellular Carcinoma (HCC), pre-treated or not with a tyrosine
kinase inhibitor and Child-Pugh B cirrhosis, ALBI (Albumin-Bilirubin) grade 1 or 2 and BCLC
(Barcelona Clinic Liver Cancer Group) B or C and with no more than 50% liver invasion of
tumour disease.