Actively Recruiting
A Phase II Single-Arm Clinical Study to Evaluate the Efficacy and Safety of Carbon Ion Radiotherapy With Atezolizumab and Bevacizumab Combination Therapy in Patients With Advanced Hepatocellular Carcinoma
Led by Yonsei University · Updated on 2025-11-24
52
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This single-center, prospective phase II clinical trial evaluates the safety and therapeutic efficacy of combining carbon ion radiotherapy with the standard first-line regimen of atezolizumab and bevacizumab in patients with advanced hepatocellular carcinoma. The study aims to determine whether the addition of carbon ion radiotherapy enhances tumor control and improves clinical outcomes beyond those achieved with systemic therapy alone. Key endpoints include overall survival, progression-free survival, objective response rate, and treatment-related adverse events.
CONDITIONS
Official Title
A Phase II Single-Arm Clinical Study to Evaluate the Efficacy and Safety of Carbon Ion Radiotherapy With Atezolizumab and Bevacizumab Combination Therapy in Patients With Advanced Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically or radiologically confirmed hepatocellular carcinoma (HCC)
- Barcelona Clinic Liver Cancer (BCLC) stage B or C, not eligible for surgery or transplantation
- At least one measurable lesion by RECIST criteria
- Eligible for atezolizumab plus bevacizumab treatment
- Candidate for carbon ion radiotherapy as determined by a radiation oncologist
- Child-Pugh class A liver function
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate organ and marrow function including: neutrophil count 1,500/bcL, platelet count 75,000/bcL, hemoglobin 8.5 g/dL, serum creatinine 1.5 �d7 ULN or creatinine clearance 50 mL/min, AST/ALT 5 �d7 ULN, total bilirubin 3 mg/dL
- No uncontrolled esophageal or gastric varices (confirmed by endoscopy within 6 months) or adequately treated before enrollment
- Able to understand and willing to sign informed consent
You will not qualify if you...
- Prior systemic therapy with anti-PD-1, anti-PD-L1, or anti-VEGF agents within the past year
- Prior carbon ion radiotherapy to the same area
- Uncontrolled or severe cardiovascular disease including recent myocardial infarction (within 6 months), uncontrolled hypertension, NYHA class III-IV heart failure
- Active or history of autoimmune disease requiring systemic immunosuppressive therapy
- Active uncontrolled infections including bacterial, viral, or fungal infections, active tuberculosis, HIV infection, or active hepatitis B/C with uncontrolled viral replication
- Significant bleeding risk including active gastrointestinal bleeding, untreated or high-risk varices, coagulopathy not controllable with standard therapy
- Portal vein tumor thrombosis (PVTT) grade Vp4 if unsuitable for treatment
- Pregnant or breastfeeding women
- History of organ transplantation including liver transplantation
- Any condition judged by the investigator to interfere with participation, compliance, or safety evaluation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Yonsei University Health System, Severance Hospital
Seoul, South Korea
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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