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AzTrials

Hepatocellular CarcinomaPhase 2NCT07246668

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

A Phase 2 study testing Carbon Ion Radiotherapy Atezolizumab Bevacizumab in people with Hepatocellular Carcinoma and Liver Neoplasms, run by Yonsei University at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Carbon Ion Radiotherapy Atezolizumab Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteSouth Korea
Study dates
10 Mar 2025to Mar 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

South Korea1 site, 1 recruiting

  • Yonsei University Health System, Severance Hospital

    Seoul

    Ik Jae Lee, +82-2-2228-8117, IKJAE412@YUHS.AC

    Recruiting

Other trials in South Korea

About this study

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.

Read the detailed description

This clinical trial aims to determine whether adding carbon ion radiotherapy to atezolizumab-bevacizumab therapy improves tumor control and enhances immune response in patients with advanced hepatocellular carcinoma. Over a 3-year study period, eligible patients receiving atezolizumab and bevacizumab who are also suitable for carbon ion radiotherapy will undergo the combined treatment. Clinical outcomes including survival, progression, radiologic response, and toxicity (graded using CTCAE v5.0) will be monitored and assessed.

Being tested
Carbon Ion Radiotherapy Atezolizumab Bevacizumab
Medical subject headings
Carcinoma, Hepatocellular, Liver Neoplasms, Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Carbon Ion Radiotherapy Atezolizumab BevacizumabRadiation

    Also called Atezolizumab: Anti-PD-L1 antibody Bevacizumab: Anti-VEGF monoclonal antibody Carbon Ion Radiotherapy: Heavy-ion radiotherapy, C-ion RT

    Participants will initiate systemic therapy with atezolizumab (1200 mg IV every 3 weeks) and bevacizumab (15 mg/kg IV every 3 weeks). Carbon ion radiotherapy will subsequently be administered to the primary hepatic lesion during the early phase of systemic therapy.

    Carbon ion radiotherapy will be delivered using a hypofractionated schedule (approximately 4-12 fractions), with dose and fractionation individualized based on tumor size, anatomical location, and organ-at-risk considerations. After completion of carbon ion radiotherapy, participants will continue maintenance treatment with atezolizumab and bevacizumab until disease progression or unacceptable toxicity.

Study groups in NCT07246668
Study groupRoleWhat they receive
Carbon Ion Radiotherapy + Atezolizumab + BevacizumabExperimentalParticipants will receive standard first-line systemic therapy with atezolizumab (1200 mg IV every 3 weeks) plus bevacizumab (15 mg/kg IV every 3 weeks). Carbon ion radiotherapy will be integrated as a sequential local treatment during the early phase of systemic therapy. Carbon ion radiotherapy will be delivered to the primary hepatic tumor using a hypofractionated regimen (approximately 4-12 fractions), with dose and fractionation individualized according to tumor extent, anatomical proximity to gastrointestinal organs, and institutional organ-at-risk constraints. Following completion of carbon ion radiotherapy, participants will continue atezolizumab-bevacizumab maintenance therapy until radiologic disease progression, unacceptable toxicity, or withdrawal of consent. This protocol is designed to enhance local tumor control while preserving the systemic therapeutic benefit of atezolizumab and bevacizumab.
Receives: Radiation: Carbon Ion Radiotherapy Atezolizumab Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS)

    Progression-free survival is defined as the time from the first administration of atezolizumab plus bevacizumab to the date of documented tumor progression or death from any cause, whichever occurs first.

    Measured: Three years

Secondary outcomes (4)

  1. Overall survival

    Overall survival is defined as the time from the first administration of atezolizumab plus bevacizumab to death from any cause.

    Surviving patients will be censored at the date of the last follow-up. OS defines death or last follow-up date from the date of first AtezoBev administration.

    Measured: Three years

  2. intrahepatic tumor response

    Tumor response will be evaluated according to RECIST criteria at predefined time points.

    Complete Response (CR): Disappearance of all target lesions Partial Response (PR): ≥30% decrease in the sum of the longest diameters of target lesions Progressive Disease (PD): ≥20% increase in the sum of the longest diameters of target lesions, or appearance of new lesions Stable Disease (SD): Does not meet criteria for CR, PR, or PD Disease Control Rate (DCR) will be measured as CR + PR + SD. (ORR = CR + PR / DCR = CR + PR + SD)

    Measured: Three years

  3. rate of achieving curative down-staging

    The proportion of patients who become eligible for curative-intent treatments after tumor down-staging will be assessed.

    Curative treatments may include liver transplantation, hepatic resection, ablation, TACE, or TARE, based on the discretion of the treating physician. How often radical treatments become possible after down-staging A decrease in stage was confirmed during the course of treatment, and treatment targeting the root, such as liver transplantation, hepatic resection, other local ablation, TACE, or TARE, is allowed at the discretion of the physician.

    Measured: Three years

  4. treatment-related toxicity

    Treatment-related adverse events will be evaluated and graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).

    Safety follow-up will continue from study entry until 30 days after the final planned dose of protocol treatment, or until initiation of subsequent alternative therapy, whichever occurs first.Toxicity is assessed using the National Cancer Society's Common Criteria for Judgment (NCI-CTC). Patients participating in the treatment are subject to safety and toxicity follow-up from participation in the study to 30 days after the final dose of the treatment under the plan is completed (or until the earliest of the start of the next alternative treatment).

    Measured: Three years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2025
  2. Study start10 Mar 2025
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
This study is designed as a single-group, open-label, prospective phase II trial evaluating the combination of carbon ion radiotherapy with atezolizumab plus bevacizumab for advanced hepatocellular carcinoma.
Masking
None (open label)
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07246668
Sponsor's protocol ID
4-2025-0048
Status last verified
Nov 2025
First submitted
17 Nov 2025
Last updated
24 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carbon Ion Radiotherapy Atezolizumab Bevacizumab in people with Hepatocellular Carcinoma and Liver Neoplasms, run by Yonsei University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: Three years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07246668.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.

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