Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 14 of 14

List	Outcome	Time frame	Description
Primary	Objective Response Rate per RECIST 1.1	From the first imaging assessment performed 4-6 weeks after completion of SBRT, repeated every 12 weeks until progression, death, or completion of 2-year follow-up	Proportion of patients achieving complete response or partial response per RECIST 1.1, assessed by investigators.
Secondary	Complete Response (CR) per RECIST 1.1	From the first imaging assessment performed 4-6 weeks after completion of SBRT, repeated every 12 weeks until progression, death, or completion of 2-year follow-up	Proportion of patients achieving complete response (disappearance of all target lesions) per RECIST 1.1, assessed by investigators.
Secondary	Disease Control Rate (DCR) per RECIST 1.1	From the first imaging assessment performed 4-6 weeks after completion of SBRT, repeated every 12 weeks until progression, death, or completion of 2-year follow-up	Proportion of patients achieving complete response, partial response, or stable disease (CR + PR + SD) per RECIST 1.1, assessed by investigators.
Secondary	Time to Response (TOR)	From enrollment to the first documented response (RECIST 1.1 and mRECIST), up to 2 years	Time from enrollment to the first documented tumor response per RECIST 1.1 and mRECIST.
Secondary	Duration of Response (DOR)	From first documented response to disease progression or death from any cause, up to 2 years	Time from first documented response until disease progression or death from any cause, per RECIST 1.1 and mRECIST.
Secondary	Local Control (LC)	From enrollment to first progression within the irradiated volume (within the 80% isodose line), assessed every 12 weeks, up to 2 years	Time from enrollment to first progression within the high-dose irradiated region (within the 80% isodose line), per RECIST 1.1 and mRECIST.
Secondary	Progression-Free Survival (PFS)	From enrollment to disease progression or death from any cause, up to 2 years	Time from enrollment to disease progression or death from any cause, per RECIST 1.1 and mRECIST.
Secondary	Time to Progression (TTP)	From enrollment to disease progression, up to 2 years	Time from enrollment to disease progression, per RECIST 1.1 and mRECIST.
Secondary	Overall Survival (OS)	From enrollment to death from any cause, up to 2 years of follow-up	Time from enrollment until death from any cause.
Secondary	Incidence of Adverse Events	From first dose of study treatment until 30 days after the last dose for adverse events and serious adverse events; safety follow-up visit 6 weeks after the last dose	Incidence, severity (CTCAE v6.0), relatedness, and outcome of adverse events and serious adverse events, including incidence of grade 3 or higher events, treatment-related events, fatal events, and events leading to treatment discontinuation.
Secondary	Composite of Quality of Life by EORTC QLQ-C30 and QLQ-HCC18	At baseline, every 1-2 weeks during radiotherapy, and at each treatment cycle until the end of treatment, up to 2 years	Quality of life assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30, version 3.0; 30 items) and its hepatocellular carcinoma-specific supplemental module (EORTC QLQ-HCC18; 18 items). All scale scores are transformed linearly to a range from 0 to 100; a higher score represents a better outcome for the global health status and functional scales, and a worse outcome for the symptom scales. Scores are calculated per the official EORTC scoring manual.
Secondary	Objective Response Rate (ORR) per mRECIST	From the first imaging assessment performed 4-6 weeks after completion of SBRT, repeated every 12 weeks until progression, death, or completion of 2-year follow-up	Proportion of patients achieving complete response or partial response (CR + PR) per modified RECIST (mRECIST), assessed by investigators.
Secondary	Complete Response (CR) per mRECIST	From the first imaging assessment performed 4-6 weeks after completion of SBRT, repeated every 12 weeks until progression, death, or completion of 2-year follow-up	Proportion of patients achieving complete response per modified RECIST (mRECIST), assessed by investigators.
Secondary	Disease Control Rate (DCR) per mRECIST	From the first imaging assessment performed 4-6 weeks after completion of SBRT, repeated every 12 weeks until progression, death, or completion of 2-year follow-up	Proportion of patients achieving complete response, partial response, or stable disease (CR + PR + SD) per modified RECIST (mRECIST), assessed by investigators.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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