Status:
COMPLETED
SIR-Spheres® Microspheres Versus Transarterial Chemoembolisation in Patients With Unresectable Hepatocellular Carcinoma
Lead Sponsor:
Sirtex Medical
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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. Patient...
Eligibility Criteria
Inclusion
- 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
- Female patients of childbearing potential must have a negative pregnancy test prior to inclusion in the trial and male and female patients must agree to use an effective contraceptive method for the duration of the trial.
- Willing and able to provide written informed consent
Exclusion
- 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
- creatinine \> 2 mg / dL
- Chemotherapy or other experimental therapy within preceding 4 weeks
- Previous TAE / TACE
- Previous radiation therapy to liver or lungs
- Contraindications for angiography (severe peripheral vascular disease or uncorrectable bleeding diathesis)
- Anatomical variants apparent on 99mTc-MAA scan precluding safe administration of RE
- Any decompensated concomitant disease
- Female patients who are pregnant, breast-feeding, or pre-menopausal and not practising efficient contraceptive method (hormonal contraceptive, intra-uterine device)
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00867750
Start Date
March 1 2006
End Date
June 1 2011
Last Update
May 7 2012
Active Locations (2)
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1
Universitäts-Klinikum München-Grosshadern, Medizinische Klinik und Poliklinik II
München, Germany, D-81377
2
Clinica Universitaria de Navarra
Pamplona, Spain, E-31008