Intra-Arterial hepatic administration of SIR-Spheres for the advanced HEPATOCARCINOMA. CLINICAL TRIAL OF PHASE II - ND

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005183-82-IT

Enrollment

Registered

2006-02-15

Start date

2005-09-15

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Hepatocarcinoma HCC MedDRA version: 6.1 Level: PT Classification code 10019697

Interventions

Pharmaceutical Form: Concentrate for solution for injection Concentration unit: MBq megabecquerel(s) Concentration type: equal Concentration number: 150-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diagnosis of HCC second the criteria of the Consensus Conference of Barcelona. The last executed diagnostic radiological surveying within 1 month from enlistment. 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 Infiltrating HCC. 2 Equivocal, not measurable or not valued tumor hepatic.

Design outcomes

Primary

Measure	Time frame
Main Objective: to estimate the impact of the administration of Sir-Spheres in terms of tolerance and clinical answer;Secondary Objective: to estimate the survival and the quality of the life;Primary end point(s): tumoral answer with the criteria RECIST	—

Countries

Italy

Outcome results

None listed

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