Tislelizumab Consolidation After Liver-Directed Therapy for Hepatocellular Carcinoma
Rutgers, The State University of New Jersey
Summary
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.
Description
Primary Objective: To determine if consolidation therapy with Tislelizumab following local therapy improves one year progression-free survival in patients with locally advanced, unresectable Hepatocellular carcinoma ( HCC). Progression-free survival (PFS) is defined as the time from first administration of Tislelizumab until the criteria for disease progression is met by response evaluation criteria in solid tumors (RECIST)1.1 or death as a result of any cause, whichever occurs first. Secondary Objectives: 1. To determine if consolidation therapy with Tislelizumab after definitive therapy i…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Each patient eligible to participate in this study must meet all the following criteria: 1. Written informed consent 2. Primary diagnosis of HCC, planned to receive radiation, treatment naïve to systemic therapy for HCC, prior TACE permitted 3. Hepatocellular carcinoma diagnosis by histologic findings and/or imaging criteria of LI-RADS 5 4. Eastern Cooperative Oncology Group performance status score of 0-2 5. Age\>/=18 years 6. Child-Pugh class A liver function or B7, BCLC A-C or deemed not a candidate for surgery or liver transplantation 7. No extrahepati…
Interventions
- DrugTislelizumab
Tislelizumab (also known as BGB A317) is a humanized, immunoglobulin G4 (IgG4)-variant monoclonal antibody against programmed cell death protein-1 (PD-1) under clinical development for the treatment of several human malignancies. Tislelizumab consolidation therapy after radiation therapy can capitalize on the immunomodulatory effect of radiotherapy and improve tumor responses and patient outcomes.
Locations (2)
- Rutgers Cancer Institute of New JerseyNew Brunswick, New Jersey
- Montefiore Medical CenterThe Bronx, New York