Actively Recruiting
A Study Comparing Immunotherapy Alone Versus Immunotherapy Combined With Radiotherapy in Patients With Hepatocellular Carcinoma (HCC) With Vascular Invasion
Led by National Cancer Center, Korea · Updated on 2025-12-26
128
Participants Needed
2
Research Sites
172 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In the present study, we aim to investigate the efficacy and safety of concurrent therapy of Immunotherapy based combination therapy and Radiotherapy in patients with advanced HCC showing macrovascular invasion.
CONDITIONS
Official Title
A Study Comparing Immunotherapy Alone Versus Immunotherapy Combined With Radiotherapy in Patients With Hepatocellular Carcinoma (HCC) With Vascular Invasion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Age 19 years or older at consent
- Diagnosis of hepatocellular carcinoma (HCC) by clinical or histological criteria
- Unresectable or advanced HCC with major vascular invasion confirmed by imaging
- At least one measurable target lesion according to RECIST v1.1
- Child-Pugh class A liver function
- ECOG performance status of 0 or 1
- Adequate blood counts and organ function within 28 days before screening
- Documented hepatitis B or C virus status, with antiviral treatment if infected
- Female participants of childbearing potential must use effective contraception or remain abstinent until 6 months after last study drug
- Male participants must agree to abstain or use condom and avoid sperm donation until 6 months after last study drug
You will not qualify if you...
- Fibrolamellar or sarcomatoid carcinoma
- Two or more prior systemic treatments for advanced HCC
- Prior systemic therapy other than immune checkpoint inhibitor as first-line
- Prior liver radiation overlapping with planned treatment area
- Locoregional therapy for HCC within 28 days before study treatment or unresolved complications
- Active or history of autoimmune or immune deficiency diseases except stable hypothyroidism, controlled type 1 diabetes, or mild chronic skin conditions
- Previous allogeneic stem cell or solid organ transplant
- Recent use of high-dose corticosteroids or immunosuppressive drugs
- History of severe allergic reactions to antibodies or fusion proteins
- Active brain or leptomeningeal metastases
- Moderate to severe ascites or hepatic encephalopathy
- Other malignancies within 2 years except low-risk cancers
- Uncontrolled severe medical conditions increasing risk
- Pregnant or breastfeeding women or unwillingness to use birth control
- Unlikely to comply with study requirements as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
National Cancer Center
Goyang, South Korea
Actively Recruiting
2
Samsung Medical Center, Seoul
Seoul, South Korea
Actively Recruiting
Research Team
Y
Yumi Yang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
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