Actively Recruiting
A Phase II Study of Carbon Ion Radiotherapy Combined With Atezolizumab and Bevacizumab in Advanced Hepatocellular Carcinoma
Led by Yonsei University · Updated on 2025-11-24
52
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of adding carbon ion radiotherapy to the standard treatment of atezolizumab and bevacizumab in patients with advanced hepatocellular carcinoma, a type of liver cancer. This phase II clinical trial aims to see if combining these treatments improves tumor control and clinical outcomes such as overall survival, progression-free survival, and response rates compared to systemic therapy alone. The study is sponsored by Yonsei University and will follow participants over a three-year period. Participants will receive standard first-line systemic therapy with atezolizumab (1200 mg intravenously every three weeks) and bevacizumab (15 mg/kg intravenously every three weeks). During the early phase of this systemic therapy, carbon ion radiotherapy will be given to the primary liver tumor using a hypofractionated schedule of about 4 to 12 treatment sessions. The exact dose and schedule will be customized based on tumor size and location to protect nearby organs. After finishing radiotherapy, participants will continue maintenance therapy with atezolizumab and bevacizumab until disease progression, unacceptable side effects, or withdrawal. Throughout the study, participants will be monitored for treatment response and safety using imaging tests and clinical evaluations. Key measures include progression-free survival over three years, overall survival, tumor response, treatment-related side effects graded by standard criteria, and the rate of tumor down-staging. The study also requires participants to have stable liver function and meet specific blood count and organ function criteria. Follow-up visits will allow the research team to track outcomes and manage any adverse events during the trial period, which is expected to end in March 2028.
CONDITIONS
Brief 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) at Barcelona Clinic Liver Cancer stage B or C
- Not eligible for curative surgery or transplantation
- At least one measurable lesion according to 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/μL, platelet count ≥ 75,000/μL, hemoglobin ≥ 8.5 g/dL
- Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance ≥ 50 mL/min
- AST/ALT ≤ 5 x upper limit of normal
- Total bilirubin ≤ 3 mg/dL
- No uncontrolled esophageal or gastric varices, confirmed by endoscopy within 6 months or adequately treated
- Ability 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 anatomical region
- 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 infection including uncontrolled bacterial, viral, or fungal infection, 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 grade Vp4 if unsuitable for treatment
- Pregnant or breastfeeding women
- History of organ transplantation including liver transplantation
- Any condition judged to interfere with participation, treatment compliance, or safety evaluation
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 3 years or until disease progression or unacceptable toxicity
Participants receive atezolizumab and bevacizumab systemic therapy every 3 weeks. Carbon ion radiotherapy is administered to the primary liver tumor with approximately 4 to 12 fractions during the early phase of systemic therapy. After completing radiotherapy, maintenance treatment with atezolizumab and bevacizumab continues until disease progression or unacceptable toxicity.
Infusions every 3 weeks; Carbon ion radiotherapy delivered in approximately 4 to 12 sessions during early treatment phase
Duration - Up to 3 years after treatment initiation
Participants are monitored for clinical outcomes including survival, tumor response, and treatment-related toxicity for up to three years.
Regular assessments scheduled throughout the study period
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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