A Phase 2 interventional study of PULSAR (Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy) and Immune checkpoint inhibitor-based therapy in Hepatocellular Carcinoma (HCC), Radiotherapy-Induced Immune Priming and Immunotherapy, sponsored by Samsung Medical Center. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Samsung Medical Center · Phase 2, Interventional, and Treatment
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:
There is no comparison group. Results will be compared with published results of immunotherapy alone.
Participants will:
3,249 studies on the registry are indexed under Carcinoma, Hepatocellular; 974 are open to participants now.
This study's planned enrollment of 38 is below the median of 55 across 2,347 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Samsung Medical Center is the lead sponsor of 1,005 studies on the registry; 148 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Radiation: PULSAR (Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy) · Drug: Immune checkpoint inhibitor-based therapy
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.
Also known as: Pulsed stereotactic adaptive radiotherapy
Drug pages: Atezolizumab · Bevacizumab
Standard-of-care immune checkpoint inhibitor-based systemic therapy chosen by the treating physician. Not provided by the study.
Also known as: Atezolizumab plus bevacizumab, Durvalumab plus tremelimumab, Nivolumab
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.
Time frame: 12 months from start of radiotherapy
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 36 months
Overall Survival
Time from start of radiotherapy to death from any cause.
Time frame: 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.
Time frame: Up to 36 months
Local Recurrence-Free Survival
Time from start of radiotherapy to first recurrence or progression within the irradiated lesion (PTV).
Time frame: Up to 36 months
Incidence of Adverse Events
Type, frequency, and severity of adverse events graded by NCI CTCAE v5.0.
Time frame: Up to 36 months
Change in Peripheral Immune Cell Subsets and Plasma Cytokines
Immune phenotyping of PBMCs by flow cytometry and plasma cytokine levels (e.g., IL-6, IL-8, IL-10, IFN-gamma).
Time frame: Before each pulse and 3 months after radiotherapy
Change in CT Radiomic Features
Radiomic features extracted from planning CT before each pulse.
Time frame: Before each pulse
Patient-Reported Adverse Events (PRO-CTCAE)
Symptomatic adverse events reported by participants using the PRO-CTCAE core set.
Time frame: Baseline through 36 months
Plan to share: 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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Atezolizumab · Bevacizumab