Actively Recruiting
A Phase II Study of Immunotherapy With or Without Particle Beam Radiation Therapy in Patients With Advanced Hepatocellular Carcinoma Who Have Vascular Invasion
Led by National Cancer Center, Korea · Updated on 2025-12-26
128
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining immunotherapy with radiotherapy compared to immunotherapy alone for patients with advanced hepatocellular carcinoma (HCC) that involves major blood vessels. This Phase II study focuses on patients with unresectable or metastatic disease showing major vascular invasion, aiming to improve treatment outcomes for this serious liver cancer. The trial includes two treatment groups: one receiving immunotherapy combined with proton beam radiation therapy, and the other receiving immunotherapy alone. The radiation dose and schedule are tailored by physicians based on normal tissue safety. Participants receive these treatments concurrently as part of the study interventions. Participants will be monitored for progression-free survival over about three years along with other outcomes like overall survival, time to progression, and response rates. The study involves regular assessments including imaging to measure tumor response and safety evaluations. This helps researchers track both treatment effects and any side effects throughout the study period.
CONDITIONS
Brief 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 the time of consent
- Histological or clinical diagnosis of hepatocellular carcinoma based on Korean Liver Cancer Association guidelines
- Unresectable, locally advanced, or metastatic disease with major vascular invasion confirmed by imaging
- At least one measurable target lesion per RECIST v1.1
- Child-Pugh class A liver function
- ECOG performance status of 0 or 1
- Adequate blood counts and organ function based on recent lab tests
- Documented hepatitis B or C virus status, with antiviral treatment if infected
- Female participants of childbearing potential agree to use effective contraception or abstain until 6 months after last study drug
- Male participants agree to use condom or abstain until 6 months after last study drug
You will not qualify if you...
- Fibrolamellar carcinoma or sarcomatoid carcinoma
- Two or more previous systemic therapies for advanced HCC
- Prior radiation therapy to the liver overlapping potential treatment area
- Locoregional therapy for HCC within 28 days before study treatment or ongoing complications
- Active or history of autoimmune disease or immune deficiency with some exceptions
- Prior allogeneic stem cell or solid organ transplant
- Recent systemic corticosteroid or immunosuppressive use
- Severe allergic reactions to antibodies or fusion proteins
- Active brain or leptomeningeal metastases
- Moderate to severe ascites or hepatic encephalopathy
- Other recent cancers with higher risk
- Severe uncontrolled medical conditions
- Pregnant or breastfeeding females, or unwillingness to use birth control
- Unlikely to comply with study procedures or requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 3 years
Participants receive immunotherapy alone or immunotherapy combined with particle beam radiation therapy as part of the study treatment.
Visits occur regularly during treatment as determined by the study team
Duration - Up to approximately 3 years
Participants are monitored for progression-free survival, overall survival, and other health outcomes after treatment.
Periodic follow-up visits to assess health status
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
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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