An international multicentre registry collecting data on patients treated with SBRT for HCC (HepReg)

An international multicentre registry collecting data on patients treated with SBRT for HCC (HepReg) - HepReg

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00038080

Enrollment

400

Registered

2025-10-13

Start date

2023-10-01

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C22.0

Interventions

Group 1: Retrospective and prospective collection of clinical patient data. Therapeutic interventions are not planned.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: The following criteria apply to both the retrospective and the prospective registry study: • Treatment of HCC with SBRT • Female and male patients aged 18 years or older • Informed consent of the patient by means of a written declaration of consent for the transmission of data to the registry (for the prospective teil) All patients who have been treated in the past will be included in the retrospective analysis. In the prospective analysis, patients receiving SBRT for HCC as part of routine medical care at one of the participating centers will be registered.

Exclusion criteria

Exclusion criteria: No exclusion criteria are defined for this registry. Any patient who meets the above inclusion criteria may be registered.

Design outcomes

Primary

Measure	Time frame
1. Late toxicities (measured according to CTCAE = Grade 3 at 3 months and annually after completion of radiotherapy for up to 2 years): Classification is performed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 / 5.0. For the analysis of incidence, the time interval is defined from the first day of treatment. Adverse events occurring within 90 days after completion of therapy are considered acute toxicities. Late toxicities are defined as adverse events that first occur more than 90 days after completion of radiotherapy. It will be assessed whether the toxicities affect organs at risk located within the radiation field. Toxicity-free survival is defined as the time from the start of radiotherapy to the occurrence of a late severe toxicity (= Grade 3 CTCAE).	—

Measure

Time frame

1. Late toxicities (measured according to CTCAE = Grade 3 at 3 months and annually after completion of radiotherapy for up to 2 years): Classification is performed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 / 5.0. For the analysis of incidence, the time interval is defined from the first day of treatment. Adverse events occurring within 90 days after completion of therapy are considered acute toxicities. Late toxicities are defined as adverse events that first occur more than 90 days after completion of radiotherapy. It will be assessed whether the toxicities affect organs at risk located within the radiation field. Toxicity-free survival is defined as the time from the start of radiotherapy to the occurrence of a late severe toxicity (= Grade 3 CTCAE).

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Secondary

Measure	Time frame
2. Overall survival (OS) Defined as the time from the start of radiotherapy to death from any cause or to the date of last follow-up. 3. Progression-free survival (PFS) Defined as the time from the start of radiotherapy to the occurrence of tumor recurrence (after prior complete remission), tumor progression, a new metastasis, or progression of a pre-existing metastasis, death from any cause, or the date of last follow-up. 4. Local recurrence-free survival (LRFS) / Local control (LC) Defined as the time from the start of radiotherapy to the occurrence of a local recurrence (after prior complete remission), local progression, death from any cause, or the date of last follow-up.	—

Measure

Time frame

2. Overall survival (OS) Defined as the time from the start of radiotherapy to death from any cause or to the date of last follow-up. 3. Progression-free survival (PFS) Defined as the time from the start of radiotherapy to the occurrence of tumor recurrence (after prior complete remission), tumor progression, a new metastasis, or progression of a pre-existing metastasis, death from any cause, or the date of last follow-up. 4. Local recurrence-free survival (LRFS) / Local control (LC) Defined as the time from the start of radiotherapy to the occurrence of a local recurrence (after prior complete remission), local progression, death from any cause, or the date of last follow-up.

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Countries

Austria, Germany

Contacts

Public ContactLivia Schmidt

Universitätsklinikum Düsseldorf

Livia.Schmidt@med.uni-duesseldorf.de+492118108603

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026