SIR-Spheres® Microspheres Versus Transarterial Chemoembolisation in Patients With Unresectable Hepatocellular Carcinoma

NCT00867750 | Completed Phase 2 DMC

• 2 other identifiers: SX-PHCC-001STX0306
• Study Type: interventional
• Target: 28
• Locations: 2 countries
• Sites: 2

Brief Summary

This study is open to patients with primary HCC who cannot be treated by potentially curative treatment modalities, such as surgical resection, liver transplantation or percutaneous ablation. Patients that satisfy the study eligibility criteria will be randomised in a 1: 1 ratio to receive either Radioembolisation with SIR-Spheres Microspheres or the standardised Transarterial Chemoembolisation procedure. Study Objectives This study will evaluate and compare quality of life as well as safety and efficacy of RE or TACE in patients with unresectable HCC. Patients will be followed for a minimum of 12 months or until death wherever possible in the evaluation of the primary and secondary objectives of this study.

Conditions

Hepatocellular Carcinoma

Keywords

HCC; RE; Yttrium-90; SIR-Spheres microspheres; TACE; Radioembolisation; Transarterial Chemoembolisation

Outcome Measures

Primary Outcomes (1)

• Health-related quality of life (HRQL)

  9 months

Secondary Outcomes (8)

• Progression Free Survival (PFS); calculated from the date of first treatment

  From the date of first treatment until disease progression

• Morphological tumour response; assessed using RESIST criteria

  From the date of first treatment until disease progression

• Functional tumour response; assessed via tumour marker reduction

  From the date of first treatment until disease progression

• Survival at 6 and 12 months

  6 and 12 months from the date of first treatment

• Overall survival

  From the date of first treatment until death

Study Arms (2)

RE

EXPERIMENTAL

Device: Radioembolisation with yttrium-90 labelled SIR-Spheres microspheres

Device: Radioembolisation (SIR-Spheres® microspheres)

TACE

ACTIVE COMPARATOR

Transarterial Chemoembolisation with embolising agent Embospheres and chemotherapeutic agent epirubicin

Drug: Transarterial Chemoembolisation

Interventions

Radioembolisation (SIR-Spheres® microspheres) DEVICE

Yttrium-90 SIR-Spheres microspheres

RE

Transarterial Chemoembolisation DRUG

TACE with embolising agent Embospheres (150-300 μm or 300-500 μm diameter) with 50 mg of chemotherapeutic agent epirubicin admixed with 5 ml lipiodol.

TACE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients, aged ≥ 18 years
• Unequivocal diagnosis of primary HCC (confirmed by biopsy/histology or EASL criteria)
• Tumour characteristics as follows:
• Not more than 5 lesions
• If single, maximal diameter ≤ 10 cm
• If multiple, sum of maximal diameters ≤ 15 cm
• Lesions satellite to primary tumour of less than 1 cm in maximal diameter are not included
• At least one quantifiable lesion on hepatic MRI
• Preserved liver function, corresponding to Child-Pugh class ≤ B-7
• ECOG performance status ≤ 2
• Life expectancy ≥ 12 weeks
• Willing and able to provide written informed consent

You may not qualify if:

• Patients expected to undergo surgery (resection or transplantation) within the 24-week period after randomisation.
• Ascites, which is detectable on physical examination or clinically symptomatic (but patients having ascites discovered by imaging only should not be excluded).
• Serum transaminases \> 5 x ULN
• Lung shunt \> 20%
• Extrahepatic disease
• Moderate to severe portal hypertension, as evidenced by any of the following criteria (occurring in spite of using common criteria for prophylactic treatment and therapy):
• History of variceal haemorrhage in past 2 years
• History of hepatic encephalopathy
• Platelets \< 50.000 /ml
• WBC \< 3.000 / ml
• Previous TIPSS procedure
• Portal vein occlusion or hepatofugal flow.
• Impaired liver function
• Total serum bilirubin \> 2.0 mg / dL
• Serum albumin \< 3.0 g /dl

Sponsors & Collaborators

• Sirtex Medical: lead

Study Sites (2)

Universitäts-Klinikum München-Grosshadern, Medizinische Klinik und Poliklinik II

München, D-81377, Germany

Location

Clinica Universitaria de Navarra

Pamplona, E-31008, Spain

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Dr Bruno Sangro, MD, PhD

  Clinica Universitaria de Navarra

  PRINCIPAL INVESTIGATOR

• Dr. Frank Kolligs, PD

  Universitäts-Klinikum München-Grosshadern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2009
• First Posted: March 24, 2009
• Study Start: March 1, 2006
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: May 7, 2012

Record last verified: 2012-05

Locations

ES (1); DE (1)