Carbon ion radiotherapy plus atezolizumab and bevacizumab for advanced hepatocellular carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, prospective Phase II trial at Yonsei University combines carbon ion radiotherapy with standard first-line atezolizumab plus bevacizumab in adults with advanced hepatocellular carcinoma who are not candidates for curative surgery or transplant. Eligible patients (BCLC stage B or C, Child‑Pugh A, ECOG 0–1, with measurable disease) will receive systemic therapy per standard dosing alongside planned carbon ion radiotherapy as determined by a radiation oncologist. The study will follow patients over approximately three years to measure overall survival, progression‑free survival, objective response rate by RECIST, and treatment‑related toxicity graded by CTCAE v5.0. Treatments and outcomes will be monitored at the single center with scheduled imaging and clinical assessments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years Histologically or radiologically confirmed hepatocellular carcinoma (HCC) Barcelona Clinic Liver Cancer (BCLC) stage B or C, not eligible for curative surgery or transplantation.

At least one measurable lesion according to RECIST criteria. Eligible for treatment with atezolizumab plus bevacizumab based on clinical judgment.

Candidate for carbon ion radiotherapy determined by radiation oncologist. Child-Pugh class A liver function Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Adequate organ and marrow function, including:

Absolute neutrophil count ≥ 1,500/μL Platelet count ≥ 75,000/μL Hemoglobin ≥ 8.5 g/dL Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min AST/ALT ≤ 5 × ULN Total bilirubin ≤ 3 mg/dL No uncontrolled esophageal or gastric varices, confirmed by endoscopy (within 6 months), or adequately treated before enrollment.

Ability to understand and willingness to sign a written informed consent form.

Exclusion Criteria:

* 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.

Presence of 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 (PVTT) of grade Vp4 if judged unsuitable for treatment by investigator.

Pregnant or breastfeeding women History of organ transplantation, including liver transplantation. Any condition judged by the investigator to interfere with study participation, treatment compliance, or safety evaluation.

Where it's running

• Yonsei University Health System, Severance Hospital
  Seoul, South Korea Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Preventive endoscopic banding for high-risk esophageal varices in people with hepatocellular carcinoma starting atezolizumab plus bevacizumab

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.