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Advanced Hepatocellular Carcinoma (HCC)Phase 2IOPTNCT06828380

A Study Comparing Immunotherapy Alone Versus Immunotherapy Combined With Radiotherapy in Patients With Hepatocellular Carcinoma (HCC) With Vascular Invasion

A Phase 2 study testing Particle beam radiation therapy in people with Advanced Hepatocellular Carcinoma (HCC), run by National Cancer Center, Korea at 2 sites 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
Search all trials

Trial summary

In the present study, we aim to investigate the efficacy and safety of concurrent therapy of Immunotherapy based combination therapy and Radiotherapy in patients with advanced HCC showing macrovascular invasion. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Advanced Hepatocellular Carcinoma (HCC)
What is being tested?
Particle beam radiation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
2 sitesSouth Korea
Study dates
15 Apr 2025to 6 Aug 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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent form
  • Age >= 19 at the time of signing Informed consent form
  • Histological or clinical diagnosis of HCC based on the guidelines of the Korean Liver Cancer Association -National Cancer Center
  • Unresectable and/or locally advanced or metastatic disease showing major vascular invasion
  • Presence of major vascular invasion on dynamic CT or dynamic MRI (1+2)
  • an intraluminal filling defect adjacent to the primary tumor in portal vein, hepatic vein, and/or inferior vena cava
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  • an enhancement of the filling defect on arterial phase and a washout on portal/delayed phases
  • Having at least one measurable target lesion (per RECIST v1.1)
  • Participants who received prior locoregional therapy (e.g., radiofrequency ablation, microwave ablation, transarterial chemoembolization, transarterial radioembolization, transarterial embolization, radiation therapy etc.) are eligible provided that other target lesion(s) have not been previously treated with locoregional therapy or the target lesion(s) within the field of locoregional therapy have subsequently progressed in accordance with RECIST v1.1.
  • Child-Pugh class A
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
  • Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 28 days prior to screening:
  • Hemoglobin ≥ 8.0 g/dL
  • Absolute neutrophil count (ANC) ≥ 1,000/mm3
  • Platelet count ≥ 50,000/μL
  • Total bilirubin < 3.0 mg/dL
  • Serum albumin ≥ 2.8 g/dL
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × the upper limit of normal (ULN)
  • Prothrombin time in INR ≤ 1.8 × ULN
  • Serum creatinine ≤ 2.0 × ULN or calculated creatinine clearance ≥ 40 mL/min (using the Cockcroft-Gault equation)
  • Documented virology status of hepatitis, as confirmed by screening tests for HBV and HCV
  • Participants with HBV or HCV infection must be treated with antiviral therapy as per institutional practice.
  • Female participants of childbearing potential must agree to either remain abstinent or use effective contraception (with a failure rate of <1% per year) since signing of the informed consent form until at least 6 months after the last study drug administration.
  • Male participants must agree to remain abstinent or use a condom and refrain from donating sperm since signing of the informed consent form until at least 6 months after the last study drug administration.

Who cannot join

  • Fibrolamellar carcinoma or sarcomatoid carcinoma
  • Receipt of 2 or more prior systemic therapy for advanced HCC. Additional prior systemic therapies used as adjuvant or local therapy are allowed.
  • Receipt of other first-line systemic therapy than immune checkpoint inhibitor-based regimen
  • Receipt of prior radiation therapy to liver
  • Participants are excluded if the potential radiation field overlaps with a previously irradiated area.
  • Receipt of locoregional therapy for HCC within 28 days prior to initiation of study treatment or non-recovery from complications due to the procedure (radiofrequency ablation, microwave ablation, cryoablation, trans-arterial embolization including chemo- and radio-embolization, or radiation therapy).
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  • A 7-day washout is permitted for palliative radiation to bone lesions
  • Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, or multiple sclerosis with following exceptions:
  • Patients with hypothyroidism stable on hormone replacement
  • Controlled type 1 diabetes mellitus and on an insulin regimen
  • Any chronic skin condition that does not require systemic therapy
  • Prior allogeneic stem cell or solid organ transplantation
  • Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to initiation of study treatment
  • History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
  • Having active brain metastasis or leptomeningeal metastasis
  • Moderate to severe or intractable ascites
  • Presence of hepatic encephalopathy
  • History of malignancy other than HCC within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate >90%)
  • Uncontrolled severe medical comorbidities, including significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to the initiation of study treatment, unstable arrhythmia, or unstable angina or any significant medical illness or abnormal laboratory findings that, in the investigator's judgement, would increase the risk to the participant associated with study participation
  • Female participants who are pregnant or breastfeeding or male or female participants of reproductive potential who are not willing to employ effective birth control from screening to 6 months after the last study drug administration
  • Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements

Trial locations and contacts

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

Yumi Yang contact

+82-10-3134-9044

75427@ncc.re.kr

South Korea2 sites, 2 recruiting

  • National Cancer Center

    Goyang

    Yumi Yang, Study coordinator, +82-31-920-0746, 75427@ncc.re.kr

    Bo Hyun Kim

    Recruiting

  • Samsung Medical Center, Seoul

    Seoul

    Soonmi Song, Study coordinator, +82-2-3410-3877, soonmisong0813@gmail.com

    Dong Hyun Shin

    Recruiting

Other trials in South Korea

About this study

Official title: A Phase II Study of Immunotherapy With or Without Particle Beam Radiation Therapy in Patients With Advanced Hepatocellular Carcinoma Who Have Vascular Invasion: IOPT Study

In the present study, we aim to investigate the efficacy and safety of concurrent therapy of Immunotherapy based combination therapy and Radiotherapy in patients with advanced HCC showing macrovascular invasion.

Being tested
Particle beam radiation therapy

What participants receive

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

  • Particle beam radiation therapyRadiation

    The prescribed dose and fractionation for proton therapy to the PTV will be determined by the physician, taking into account the dose-volume constraints of normal tissues such as the liver and bowel.

Study groups in NCT06828380
Study groupRoleWhat they receive
Arm AExperimentalconcurrent therapy of Immunotherapy based combination therapy and Proton beam radiation therapy
Receives: Radiation: Particle beam radiation therapy
Arm BNo interventionconcurrent therapy of Immunotherapy based combination therapy

What is being measured

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

  1. PFS (Progression-free survival)

    PFS is defined as the time from the date of treatment initiation to the date of the first observation of progressive disease (PD) by the investigator according to RECIST v1.1 criteria or death from any cause.

    Measured: up to approximately 3 years

Secondary outcomes (6)

  1. OS(overall survival)

    OS is defined as the time from the date of treatment initiation to the date of death from any cause.

    Measured: up to approximately 3 years

  2. TTP(Time to progression)

    TTP is defined as the time from the date of treatment initiation to the date of the first observation of PD by the investigator according to RECIST v1.1 criteria.

    Measured: up to approximately 3 years

  3. ORR(Objective response rate)

    ORR is defined as the proportion of participants whose best overall response is CR or PR as determined by the investigator according to RECIST v1.1 criteria.

    Measured: up to approximately 3 years

  4. DCR(Disease control rate)

    DCR is defined as the proportion of participants whose best overall response is a CR, PR, or SD as determined by the investigator according to RECIST v1.1 criteria.

    Measured: up to approximately 3 years

  5. DoR(Duration of response)

    DoR is defined as the time interval from the date of the first occurrence of a documented objective response (CR or PR, whichever occurs first) until the first date that disease progression or death is documented, whichever occurs first.

    Measured: up to approximately 3 years

  6. TTR(Time to response)

    TTR is defined as the time from the date of treatment initiation to the date of the first observation of a documented objective response (CR or PR, whichever occurs first).

    Measured: up to approximately 3 years

Timeline

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

  1. First posted14 Feb 2025
  2. Study start15 Apr 2025
  3. Primary completion6 Aug 2028 (estimated)
  4. Study completion6 Aug 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
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
128 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06828380
Sponsor's protocol ID
NCC2024-0308
Acronym
IOPT
Status last verified
Dec 2025
First submitted
27 Jan 2025
Last updated
26 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Particle beam radiation therapy in people with Advanced Hepatocellular Carcinoma (HCC), run by National Cancer Center, Korea at 2 sites 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 24 inclusion and 21 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 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Contact Yumi Yang (+82-10-3134-9044, 75427@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (Progression-free survival) (time frame: up to approximately 3 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 NCT06828380.

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 26 Dec 2025.

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