Tests adaptive radiotherapy with immunotherapy for advanced liver cancer
Tests adding personalized radiotherapy to immunotherapy in adults with advanced liver cancer.
Plain-language title generated from the registry record
Registry title: PULSAR Radiotherapy Combined With Immunotherapy for High-Risk Advanced Liver Cancer
Key facts
- Where
- Seoul, South KoreaSee the site
- Phase
- Phase 2
Where in South Korea
- Samsung Medical CenterSeoul, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Samsung Medical Center
- Trial code
- NCT07884877
- Record updated
- 21 October 2026
- Original description
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:Read full original descriptionShow less
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?
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
Inclusion: 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.
Exclusion: Prior radiotherapy to the treatment site; 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); 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.