Evaluation of the Efficacy of Long-acting Release Octreotide in Patients With Advanced Hepatocellular Carcinoma

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Octreotide

Criteria

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