Tislelizumab Consolidation After Liver-Directed Therapy for Hepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRutgers, The State University of New Jersey
About this trial
The investigators hypothesize that the addition of Tislelizumab after definitive local therapy for locally advanced inoperable Hepatocellular carcinoma (HCC) will synergize with local therapy as well as treat micro metastatic disease and improve one year progression-free survival rates for participants and optimize local control.
Eligibility criteria
Qualifiers
Written informed consent
Primary diagnosis of HCC, planned to receive radiation, treatment naïve to systemic therapy for HCC, prior TACE permitted
Hepatocellular carcinoma diagnosis by histologic findings and/or imaging criteria of LI-RADS 5
Eastern Cooperative Oncology Group performance status score of 0-2
Disqualifiers
Prior radiotherapy to the region of the liver that would result in excessive doses to normal tissues due to overlap of radiation therapy fields
Prior selective internal radiotherapy/hepatic arterial Yttrium therapy, at any time
Severe, active co-morbidity as per investigator
More than five discrete intrahepatic parenchymal foci of definite HCC or left/right or main portal vein thrombus
Trial design
Treatments tested in this trial
- Tislelizumab
Treatment groups
35 Participants
are divided into 1 treatment groupSponsors and collaborators
Rutgers, The State University of New Jersey
Lead sponsor
BioGene Pharmaceutical Ltd.
Collaborator
Natera, Inc.
Collaborator
Source ClinicalTrials.gov