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NOT YET RECRUITING
NCT07895732
PHASE3

Personalized Adaptive Radiotherapy for Hepatocellular Carcinoma

Sponsor: University Health Network, Toronto

View on ClinicalTrials.gov

Summary

This study evaluates whether Personalized Ultrafractionated Stereotactic Adaptive Radiation Therapy (PULSAR) improves overall survival compared with best supportive care (BSC). The main questions this study aims to answer are: Does PULSAR improve overall survival compared with BSC? Does PULSAR delay deterioration in patient-reported outcomes and quality of life compared with BSC? Can adaptive radiotherapy delivered in ultrafractionated pulses improve the therapeutic ratio in patients with HCC and poor liver function? The study will compare PULSAR with BSC to evaluate differences in survival, disease control, liver function, and treatment-related toxicity. Participants randomized to the PULSAR arm will receive 24 Gy of radiation delivered in 3 fractions of 8 Gy each, administered every 3 weeks using adaptive stereotactic radiotherapy. Participants in the BSC arm will receive standard supportive care. All participants will undergo regular assessments of survival, disease progression, liver function, toxicities, and quality of life.

Official title: Personalized Ultrafractionated Stereotactic Adaptive Radiation Therapy for Hepatocellular Carcinoma With Child Pugh B8-9 (PULSAR-HCC): Phase III Randomized Controlled Trial.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-12-01

Completion Date

2031-12-01

Last Updated

2026-10-26

Healthy Volunteers

No

Interventions

OTHER

Best Supportive Care (BSC)

Palliative Care

RADIATION

Personalized ultrafractionated stereotactic adaptive radiation therapy (PULSAR)

SBRT pulses: 8Gy per pulse every 3 weeks up to 3 pulses

Locations (1)

Princess Margaret Cancer Center

Toronto, Ontario, Canada