NCT07884877RecruitingPhase 2
PULSAR Radiotherapy Combined With Immunotherapy for High-Risk Advanced Liver Cancer
A Prospective Phase II Study of Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy (PULSAR) Combined With Immunotherapy in Patients With Advanced Hepatocellular Carcinoma
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
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? 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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 38 (estimated)
- First submitted
- 13 Oct 2026
- Start date
- 15 Oct 2026
- Primary completion date
- Oct 2028
- Lead sponsor
- Samsung Medical Center
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07884877
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 38
- From 15 Oct 2026 to the primary completion date, Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior radiotherapy to the treatment site
Other illness
- 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)
- 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)
Other
- Pregnant or breastfeeding women
- Active brain or leptomeningeal metastases
- More than 5 extrahepatic metastatic lesions (multiple intrahepatic lesions are allowed)
- Moderate or refractory ascites, or hepatic encephalopathy
- Unable to comply with the study protocol
- Considered unsuitable for the study by the investigator
Who the study is looking for
- 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)
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.