Actively Recruiting
Tislelizumab Consolidation After Liver-Directed Therapy for Hepatocellular Carcinoma
Led by Rutgers, The State University of New Jersey · Updated on 2026-01-20
35
Participants Needed
2
Research Sites
253 weeks
Total Duration
On this page
Sponsors
R
Rutgers, The State University of New Jersey
Lead Sponsor
B
BioGene Pharmaceutical Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tislelizumab Consolidation After Liver-Directed Therapy for Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent
- Primary diagnosis of hepatocellular carcinoma planned for radiation treatment; prior transarterial chemoembolization allowed
- Diagnosis confirmed by histology or imaging criteria (LI-RADS 5)
- Eastern Cooperative Oncology Group performance status of 0 to 2
- Age 18 years or older
- Child-Pugh class A liver function or B7, BCLC stage A to C, or not a candidate for surgery or liver transplant
- No extrahepatic metastasis detected by chest CT and abdomen/pelvis imaging
- Females of childbearing potential must use effective birth control during and for 6 months after treatment and have a negative pregnancy test within 7 days before first dose
- Non-sterile males must use effective birth control during and for 6 months after treatment and agree not to donate sperm during this time
- At least one measurable target lesion per RECIST 1.1
- Adequate bone marrow and organ function including specific blood counts, kidney function within limits, and liver function tests within defined thresholds
You will not qualify if you...
- Prior radiotherapy to the liver region that would cause excessive normal tissue exposure
- Prior internal radiotherapy with Yttrium or selective internal radiotherapy
- Severe active co-morbidities
- More than five discrete intrahepatic HCC foci or significant portal vein thrombus
- Tumor extension into stomach or intestines
- Measurable biliary duct involvement
- Extrahepatic metastases or malignant lymph nodes larger than 3 cm total diameter
- Prior liver transplant
- HIV positive status
- Immunodeficiency requiring systemic therapy or relapse risk
- Previous immunotherapy treatment
- Clinically significant ascites requiring paracentesis
- Clinically meaningful encephalopathy
- Prior solid organ or bone marrow transplant (except prior renal transplant with dialysis plan)
- Active hepatitis B infection without viral suppression or co-infection with hepatitis C
- Uncontrolled autoimmune diseases or significant dermatologic conditions exceeding defined severity
- Other recent malignancies within 5 years except certain treated cancers
- Live attenuated vaccine within 4 weeks prior to treatment
- Recent systemic corticosteroids or immunosuppressants use beyond allowed exceptions
- Uncontrolled diabetes or significant electrolyte abnormalities
- History of severe lung disease or infections
- Major surgery within 28 days prior to treatment
- Recent cardiac events or severe cardiovascular conditions
- Use of herbal cancer treatments within 14 days prior to study drug
- Ongoing toxicities from prior cancer therapies not resolved
- Medical or substance abuse conditions that impair study compliance
- Participation in other therapeutic clinical studies concurrently
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
2
Montefiore Medical Center
The Bronx, New York, United States, 10451
Actively Recruiting
Research Team
S
Salma Jabbour, MD
CONTACT
P
Patrick Boland, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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