Study of Radioembolization (RE) with SIR-Spheres® versus Transarterial Chemoembolisation (TACE) in patients with unresectable primary Hepatocellular Carcinoma. A comparative, prospective, randomised, open, pilot trial to evaluate health-related quality of life, pharmaco-economic parameters, and efficacy. - SIRTACE-HCC pilot study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006478-79-DE

Enrollment

Registered

2007-05-16

Start date

2007-07-16

Completion date

Unknown

Last updated

2012-05-29

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

Conditions

Unresectable primary hepatocellular carcinoma (pHCC) MedDRA version: 9.1 Level: LLT Classification code 10019828 Term: Hepatocellular carcinoma non-resectable

Interventions

Trade Name: Farmorubicin Product Name: Epirubicine Product Code: Epirubicine in Lipiodol Pharmaceutical Form: Solution for infusion INN or Proposed INN: Epirubicine Current Sponsor code: Epirubicine C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with unresectable pHCC, diagnosis established according to EASL criteria, and - Liver function: Child-Pugh A - Performance status: ECOG 12 weeks Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: (1) Patients expected to undergo surgery (resection or transplantation) within the 24-week period after randomization. (2) Ascites, detectable on physical examination or clinically symptomatic (3) Serum transaminases higher than 5 times the upper normal limit (4) Serum bilirubin > 2 mg/dL (5) Lung shunt > 15% (6) Extrahepatic disease (7) Moderate to severe portal hypertension (10) Impaired renal function (creatinine > 2 mg / dl) (11) Chemotherapy or other experimental therapy within preceding 4 weeks (12) Previous TAE / TACE (13) Previous radiation therapy to liver or lungs (14) Contraindications for angiography (severe peripheral vascular disease or uncorrectable bleeding diathesis) (15) Anatomical variants apparent on 99mTc-MAA scan precluding safe administration of RE (16) Any decompensated concomitant disease

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluation of health-related quality of life after radioembolization (RE) with SIR-Spheres versus Transarterial Chemoembolisation (TACE) in patients with unresectable, primary hepatocellular carcinoma.;Secondary Objective: Comparative evaluation of pharmaco-economic parameters and explorative comparison of safety and efficacy of RE and TACE;Primary end point(s): The primary objective of this trial is to assess health-related quality of life (HRQL) following RE or TACE at 3, 6, and 9 months following the first treatment with either modality (HRQL3M, HRQL6M, HRQL9M), using the FACT-Hep questionnaire. The primary endpoint, therefore, is the total FACT-Hep score per treatment group at 3, 6, and 9 months.	—

Measure

Time frame

Main Objective: Evaluation of health-related quality of life after radioembolization (RE) with SIR-Spheres versus Transarterial Chemoembolisation (TACE) in patients with unresectable, primary hepatocellular carcinoma.;Secondary Objective: Comparative evaluation of pharmaco-economic parameters and explorative comparison of safety and efficacy of RE and TACE;Primary end point(s): The primary objective of this trial is to assess health-related quality of life (HRQL) following RE or TACE at 3, 6, and 9 months following the first treatment with either modality (HRQL3M, HRQL6M, HRQL9M), using the FACT-Hep questionnaire. The primary endpoint, therefore, is the total FACT-Hep score per treatment group at 3, 6, and 9 months.

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Countries

Germany

Outcome results

None listed

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