PULSAR radiotherapy plus immunotherapy for high-risk advanced liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial investigates the safety and potential benefit of combining PULSAR, a personalized adaptive stereotactic radiotherapy, with immune checkpoint inhibitor therapy in adults with unresectable or locally advanced/metastatic hepatocellular carcinoma. Participants continue their planned immunotherapy and receive 2–3 PULSAR sessions spaced 3–4 weeks apart, with treatment plans adjusted before each session. The study tracks overall survival without progression at 12 months and records immune- and treatment-related adverse events over up to 3 years, comparing results to published immunotherapy data. No randomized control group is included; outcomes will be interpreted against historical data for immunotherapy alone.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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)
* 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

Where it's running

• Samsung medical center
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Nalee Kim, MD, PhD
• Email: rodr.naleekim@gmail.com
• Phone: 82-2-3410-2612

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.