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Recruiting
NCT07884877
PULSAR Radiotherapy Combined With Immunotherapy for High-Risk Advanced Liver Cancer
Conditions: Hepatocellular Carcinoma (HCC), Radiotherapy-Induced Immune Priming, Immunotherapy
Sex: All
Ages: 19 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 38
Sponsor: Samsung Medical Center
Location: Samsung medical center Seoul
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. 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
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07884877). StuddyBuddy aggregates publicly available trial information.