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

Novartis

Status and phase: Completed; Phase 3

Conditions: Advanced Hepatocellular Carcinoma

Treatments: Drug: Octreotide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00241020

CSMS995BFR04

Details and patient eligibility

About

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.

Enrollment: 270 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Triple Blind

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270 participants in 1 patient group

Octreotide

Experimental group

Treatment:

Drug: Octreotide