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

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
First received: October 14, 2005
Last updated: April 11, 2016
Last verified: April 2016
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.

Condition Intervention Phase
Advanced Hepatocellular Carcinoma
Drug: Octreotide
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Long-acting Release Octreotide in Patients With Advanced Hepatocellular Carcinoma

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Overall Survival

Secondary Outcome Measures:
  • Objective response
  • Survival without progression
  • Digestive bleeding
  • Renal insufficiency
  • Quality of life
  • · Safety

Enrollment: 270
Study Start Date: June 2002
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Octreotide Drug: Octreotide


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00241020

Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00241020     History of Changes
Other Study ID Numbers: CSMS995BFR04 
Study First Received: October 14, 2005
Last Updated: April 11, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Novartis:
hepatocellular carcinoma

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 30, 2016