HEpatocellular carcinoma stereotactic RAdiotherapy CLinical Evaluation Study

HEpatocellular carcinoma stereotactic RAdiotherapy CLinical Evaluation Study - HERACLES

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00008566

Enrollment

Registered

2016-03-10

Start date

2016-07-19

Completion date

Unknown

Last updated

2025-04-07

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: Diagnosis of hepatocellular carcinoma, indication: Stereotactic Body Radiotherapy. Treatment with SBRT. Keeping record of recruitment, toxicity and outcome parameters. Group 2: Diagnosis of

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Histologically or cytologically confirmed hepatocellular carcinoma OR diagnosis made with characteristic enhancement in 4-Phase CT or MRI corresponding to AASLD- / EASL guidelines in cirrhotic patients; Discussion in a routine multidisciplinary tumour board; Understanding of procedure, significance and consequences of the study; given informed consent. SBRT Group: Patients unsuitable for surgery, TACE*, RFA, or alcohol ablation / *TACE patients will be recruited for control group; bilirubin has to be < 4 x the upper limit of normal, AST or ALT < 6 x the upper limit of normal, international normalized ratio < 1.5 except if patients are on oral anticoagulation, haemoglobin= 90 g/L, platelets = 50 x 10^9/L, and neutrophils = 1.0 x 10^9/L. TACE Group: Patients suitable for TACE; bilirubin has to be <2 mg/dL, AST or ALT < 6 x the upper limit of normal, international normalized ratio < 1.5 except if patients are on oral anticoagulation, haemoglobin= 90 g/L, platelets = 50 x 10^9/L, and neutrophils = 1.0 x 10^9/L

Exclusion criteria

Exclusion criteria: Child-Turcotte-Pugh (CTP) C liver score; Hepatic encephalopathy more than Grade 1 according to Child Pugh criteria; Active hepatitis; Gastric, duodenal or variceal bleed within 2 months of registration; Prior radiotherapy of the region to be treated; For female patients: Pregnancy, planned pregnancy

Design outcomes

Primary

Measure	Time frame
Feasibility, i.e. recruitment and conduct of a prospective study using SBRT or TACE according to their standard medical indications	—

Secondary

Measure	Time frame
Toxicity acute and late measured as NCI-CTCAE v4.0, progression free survival (PFS), overall survival (OS)	—

Countries

Germany

Contacts

Public ContactSimon Kirste

Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde

simon.kirste@uniklinik-freiburg.de+49 761 270 94510

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026