RecruitingPhase 2NCT05366829

Tislelizumab Consolidation After Liver-Directed Therapy for Hepatocellular Carcinoma


Sponsor

Rutgers, The State University of New Jersey

Enrollment

35 participants

Start Date

Jul 25, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an immunotherapy drug called tislelizumab (a checkpoint inhibitor) given after liver-directed treatments (such as radiation or TACE) for patients with hepatocellular carcinoma (liver cancer). Researchers want to see if adding immunotherapy after local liver treatment improves outcomes. **You may be eligible if...** - You have been diagnosed with primary liver cancer (hepatocellular carcinoma) - You have not yet received systemic (whole-body) treatment for liver cancer - You do not have cancer that has spread outside the liver - You are 18 or older and in reasonably good health (ECOG 0–2) - Your liver function is acceptable (Child-Pugh A or B7) - You have measurable disease **You may NOT be eligible if...** - You have previously had immunotherapy - You have had a liver transplant - You are HIV positive - You have uncontrolled hepatitis B or C infection - You have significant fluid buildup in the abdomen (ascites requiring procedures) - You have had a heart attack, stroke, or heart failure in the past 6 months - You have a history of autoimmune lung disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Jersey

New Brunswick, New Jersey, United States

Montefiore Medical Center

The Bronx, New York, United States

View Full Details on ClinicalTrials.gov

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NCT05366829


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