Evaluation of the Efficacy of Long-acting Release Octreotide in Patients With Advanced Hepatocellular Carcinoma
- Registration Number
- NCT00241020
- Lead Sponsor
- Novartis Pharmaceuticals
- 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 currently available. The objective of this study is to assess the efficacy and safety of octreotide in patients with advanced hepatocellular carcinoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 270
Inclusion Criteria
- > 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Octreotide Octreotide -
- Primary Outcome Measures
Name Time Method Overall Survival
- Secondary Outcome Measures
Name Time Method Digestive bleeding Objective response Survival without progression Renal insufficiency Quality of life · Safety