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

Advanced Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00241020
• Other study ID #: CSMS995BFR04
• Status: Completed
• Phase: Phase 3
• First received: October 14, 2005
• Last updated: April 11, 2016
• Start date: June 2002
• Est. completion date: October 2005

Study information

• Verified date: April 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Hepatocellular Carcinoma
• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• Octreotide

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival
Secondary	Objective response
Secondary	Survival without progression
Secondary	Digestive bleeding
Secondary	Renal insufficiency
Secondary	Quality of life
Secondary	· Safety