Status:
COMPLETED
Evaluation of the Efficacy of Long-acting Release Octreotide in Patients With Advanced Hepatocellular Carcinoma
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Advanced Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Hepatocellular carcinoma (HCC) is one of the most common malignant disease worldwide with an increasing incidence in industrialized countries. For patients with advanced HCC no efficient treatment is ...
Eligibility Criteria
Inclusion
- \> 18 years
- HCC diagnosis :
- histologically or cytologically proven HCC
- or association of the three following criteria:
- cirrhosis
- typical measurable mass (\> 3cm, by 2 methods)
- serum alpha-foetoprotein (AFP) ≥500 µg/L
- Cancer Liver Italian Program (CLIP) score : 0 to 3
- Not eligible for specific treatment (surgery, percutaneous ablation or chemo-embolization)
Exclusion
- Glycemia \> 2.5 g/L or hypoglycemia
- Extra hepatic life-threatening disease
- Serum creatinin\> 120 µmol/L
- Prothrombin time \< 50 %
- Platelet count \< 50.000 /µL
- Symptomatic cholelithiasis
- Non-measurable tumor
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT00241020
Start Date
June 1 2002
End Date
October 1 2005
Last Update
April 12 2016
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