Hepatocellular Carcinoma (HCC)Phase 2HCC-PULSARNCT07884877
PULSAR Radiotherapy Combined With Immunotherapy for High-Risk Advanced Liver Cancer
A Phase 2 study testing PULSAR (Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy) and Immune checkpoint inhibitor-based therapy in people with Hepatocellular Carcinoma (HCC) and Radiotherapy-Induced Immune Priming, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The goal of this clinical trial is to learn if adding PULSAR, a personalized adaptive stereotactic radiotherapy, to standard immunotherapy can control cancer longer in adults with high-risk advanced hepatocellular carcinoma (liver cancer). It will also learn about the safety of this combination. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC), Radiotherapy-Induced Immune Priming, Immunotherapy
- What is being tested?
- PULSAR (Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy) and Immune checkpoint inhibitor-based therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Oct 2026to Oct 2030
- Phase
- Phase 2
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
- Age 19 years or older
- Hepatocellular carcinoma diagnosed histologically or clinically according to the Korean Liver Cancer Association-National Cancer Center guidelines
- Unresectable and/or locally advanced or metastatic disease, currently receiving or scheduled to receive immune checkpoint inhibitor-based systemic therapy (e.g., atezolizumab plus bevacizumab or durvalumab plus tremelimumab)
- At least one of the following high-risk features:
- Tumor larger than 5 cm in maximum diameter
- Portal vein tumor thrombosis (Vp2-4)
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- Infiltrative lesion
- Bile duct invasion
- Inferior vena cava invasion
- Extrahepatic metastasis
- At least one measurable target lesion per RECIST version 1.1, with PULSAR already planned by the treating physician
- ECOG performance status 0-1
- Child-Pugh score 7 or lower
- Known hepatitis B and C virus status, with antiviral therapy per institutional policy if indicated
- Voluntary written informed consent
Who cannot join
- Pregnant or breastfeeding women
- Active brain or leptomeningeal metastases
- More than 5 extrahepatic metastatic lesions (multiple intrahepatic lesions are allowed)
- Prior radiotherapy to the treatment site
- Moderate or refractory ascites, or hepatic encephalopathy
- Contraindications to immune checkpoint inhibitors, such as active autoimmune disease requiring systemic treatment (hypothyroidism stable on hormone replacement and type 1 diabetes controlled with insulin are allowed)
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- Uncontrolled serious comorbidities (e.g., uncontrolled infection, NYHA class II or higher heart disease, myocardial infarction or stroke within 3 months, unstable angina or arrhythmia)
- Unable to comply with the study protocol
- Considered unsuitable for the study by the investigator
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
- Recruiting
Samsung medical center
Seoul, 06351
Nalee Kim, 82-2-3410-2612, rodr.naleekim@gmail.com
About this study
Official title: A Prospective Phase II Study of Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy (PULSAR) Combined With Immunotherapy in Patients With Advanced Hepatocellular Carcinoma
The goal of this clinical trial is to learn if adding PULSAR, a personalized adaptive stereotactic radiotherapy, to standard immunotherapy can control cancer longer in adults with high-risk advanced hepatocellular carcinoma (liver cancer). It will also learn about the safety of this combination. The main questions it aims to answer are:
- What percentage of participants are alive without cancer progression 12 months after starting PULSAR?
- What medical problems do participants have after PULSAR with immunotherapy?
Read more
There is no comparison group. Results will be compared with published results of immunotherapy alone.
Participants will:
- Continue their usual immunotherapy
- Receive 2 to 3 PULSAR sessions, 3 to 4 weeks apart, with the plan adjusted before each session
- Give blood samples and fill out symptom questionnaires
- Have checkups and scans for up to 3 years
- Being tested
- PULSAR (Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy), Immune checkpoint inhibitor-based therapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PULSAR (Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy)Radiation
Also called Pulsed stereotactic adaptive radiotherapy
Stereotactic radiotherapy (photon or proton), 8-12 Gy per pulse, 2-3 pulses at 3- to 4-week intervals, delivered between immunotherapy cycles. CT-based adaptive re-planning is performed before each pulse, with target volume reduced according to tumor response.
Immune checkpoint inhibitor-based therapyDrug
Also called Atezolizumab plus bevacizumab, Durvalumab plus tremelimumab, Nivolumab
Standard-of-care immune checkpoint inhibitor-based systemic therapy chosen by the treating physician. Not provided by the study.
| Study group | Role | What they receive |
|---|---|---|
| PULSAR Plus Immunotherapy | Experimental | Participants continue standard-of-care immune checkpoint inhibitor-based therapy (e.g., atezolizumab plus bevacizumab, durvalumab plus tremelimumab, or nivolumab) and receive PULSAR (photon or proton), 8-12 Gy per pulse, 2-3 pulses at 3- to 4-week intervals between immunotherapy cycles, with CT-based adaptive re-planning before each pulse. Receives: Radiation: PULSAR (Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy); Drug: Immune checkpoint inhibitor-based therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-Month Progression-Free Survival Rate
Proportion of participants alive without progression (RECIST v1.1) or death at 12 months from the start of radiotherapy, estimated by the Kaplan-Meier method.
Measured: 12 months from start of radiotherapy
Secondary outcomes (7)
Progression-Free Survival
Time from start of radiotherapy to progression (RECIST v1.1) or death from any cause, whichever occurs first; median estimated by the Kaplan-Meier method.
Measured: Up to 36 months
6-Month Progression-Free Survival Rate
Proportion of participants alive without progression (RECIST v1.1) or death at 6 months from the start of radiotherapy, estimated by the Kaplan-Meier method.
Measured: 6 months from start of radiotherapy
Objective Response Rate
Proportion of participants with a best overall response of complete or partial response per RECIST v1.1.
Measured: Up to 36 months
Overall Survival
Time from start of radiotherapy to death from any cause.
Measured: Up to 36 months
Disease Control Rate
Proportion of participants with a best overall response of complete response, partial response, or stable disease per RECIST v1.1.
Measured: Up to 36 months
Local Recurrence-Free Survival
Time from start of radiotherapy to first recurrence or progression within the irradiated lesion (PTV).
Measured: Up to 36 months
Incidence of Adverse Events
Type, frequency, and severity of adverse events graded by NCI CTCAE v5.0.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nalee Kim, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884877
- Sponsor's protocol ID
- SMC 2026-07-217
- Acronym
- HCC-PULSAR
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the informed consent and institutional review board approval do not permit disclosure of individual-level data outside the study team under Korean data protection regulations. Aggregate results will be published in peer-reviewed journals.