Carbon ion radiotherapy plus atezolizumab and bevacizumab for advanced hepatocellular carcinoma
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
PHASE2 · Yonsei University · NCT07246668
This trial will try adding carbon ion radiotherapy to standard atezolizumab‑bevacizumab treatment for adults with advanced hepatocellular carcinoma to see if it controls tumors better and improves survival.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Yonsei University (other) |
| Drugs / interventions | atezolizumab, bevacizumab, radiation |
| Locations | 1 site (Seoul) |
| Trial ID | NCT07246668 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with advanced hepatocellular carcinoma (BCLC B or C) who are ineligible for curative surgery or transplant, have Child‑Pugh A liver function, ECOG 0–1, at least one measurable lesion, and are both eligible for atezolizumab‑bevacizumab and judged suitable for carbon ion radiotherapy.
Not a fit: Patients with poorer liver function (Child‑Pugh B/C), ECOG performance status >1, uncontrolled varices, diffuse disease not amenable to focal radiotherapy, or who cannot tolerate immunotherapy or anti‑VEGF therapy are unlikely to benefit from this combined approach.
Why it matters
Potential benefit: If successful, adding carbon ion radiotherapy could improve local tumor control, increase progression‑free and overall survival, and possibly enhance anti‑tumor immune responses beyond systemic therapy alone.
How similar studies have performed: Atezolizumab plus bevacizumab is an established first‑line therapy in HCC and carbon ion radiotherapy has shown promising local control in small series, but combining carbon ion radiation with immunotherapy in HCC remains largely experimental without randomized evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Seoul
- Yonsei University Health System, Severance Hospital — Seoul, South Korea (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hepatocellular Carcinoma, Liver Neoplasms, Carcinoma, Hepatocellular