Actively Recruiting
Comparison of SBRT and SIRT With Combination IO for Locally-advanced, Unresectable HCCs (BIIRTH)
Led by Tuen Mun Hospital · Updated on 2026-04-09
106
Participants Needed
1
Research Sites
560 weeks
Total Duration
On this page
Sponsors
T
Tuen Mun Hospital
Lead Sponsor
Q
Queen Mary Hospital, Hong Kong
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to compare the safety and efficacy of sequential Transarterial Chemoembolization (TACE) and Stereotactic body radiation therapy (SBRT) versus Y90-radioembolisation (SIRT), followed by systemic therapy in patients with large, locally advanced, unresectable Hepatocellular carcinoma (HCC). The main question it aims to answer is whether Sequential TACE-SBRT potentially gives longer Progression-free survival (PFS) benefit with similar toxicities as compared with Y90 SIRT. Participants will be recruited via multidisciplinary meetings (MDTs) with hepatobiliary surgeons, medical hepatologists and radiologists with consistent, strict considerations on eligibility and treatment alternatives. Eligible patients will be randomized in 1:1 ratio to received one of the two treatment arms.
CONDITIONS
Official Title
Comparison of SBRT and SIRT With Combination IO for Locally-advanced, Unresectable HCCs (BIIRTH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with hepatocellular carcinoma (HCC) by biopsy or accepted criteria
- Aged 18 to 80 years
- Unresectable HCC due to tumor location, insufficient liver volume, or liver function
- Barcelona Clinic Liver Cancer stage B2-4 or C
- Tumor size 5 cm or larger with at least one measurable lesion
- Performance status of 0-1
- Expected to live at least 3 months
- Child-Pugh score between A5 and B7
- Adequate blood counts and organ function as specified
- Liver volume minus tumor volume greater than 700 cc
- If hepatitis B positive, receiving antiviral therapy with viral suppression
- Provided informed consent
- Women of childbearing potential and sexually active men must use effective contraception
- Negative pregnancy test for women of childbearing potential
You will not qualify if you...
- History of invasive cancer within 2 years except certain noninvasive cancers
- Cancer spread outside the liver
- Involvement of main portal vein or inferior vena cava
- Active uncontrolled varices
- Severe uncontrolled heart or brain blood vessel diseases or recent events
- Prior non-curative local or systemic therapy for HCC
- Prior treatment with immune checkpoint inhibitors or similar agents
- Use of systemic steroids or immunosuppressants within 14 days, except certain forms
- Active or recent autoimmune or inflammatory diseases, except some controlled conditions
- Positive HIV or immunodeficiency or organ transplant
- Live vaccine within 28 days before treatment
- Severe allergy to monoclonal antibodies
- Allergy to cisplatin or contraindications to TACE, SBRT, or SIRT as specified
- Tumor larger than 25 cm or direct invasion into gastrointestinal organs
- Lung shunting or risk of radiation exposure to lungs above limits
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tuen Mun Hospital
Hong Kong, Hong Kong
Actively Recruiting
Research Team
S
Sean Man Natalie WONG
CONTACT
M
Man TONG
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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