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RECRUITING
NCT07884877
PHASE2

PULSAR Radiotherapy Combined With Immunotherapy for High-Risk Advanced Liver Cancer

Sponsor: Samsung Medical Center

View on ClinicalTrials.gov

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

Official title: A Prospective Phase II Study of Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy (PULSAR) Combined With Immunotherapy in Patients With Advanced Hepatocellular Carcinoma

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

38

Start Date

2026-10-15

Completion Date

2030-10

Last Updated

2026-10-21

Healthy Volunteers

No

Interventions

RADIATION

PULSAR (Personalized Ultrafractionated Stereotactic Adaptive Radiotherapy)

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.

DRUG

Immune checkpoint inhibitor-based therapy

Standard-of-care immune checkpoint inhibitor-based systemic therapy chosen by the treating physician. Not provided by the study.

Locations (1)

Samsung medical center

Seoul, South Korea