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

Phase 3

Completed

• Conditions: Advanced Hepatocellular Carcinoma
• Interventions: Drug: Octreotide

• 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

Study Timeline

• Study Start: 2002-06
• Primary Completion: 2005-10
• Study Completion: 2005-10
• Study First Submitted: 2005-10-14
• Study First Submitted QC: 2005-10-16
• Study First Posted: 2005-10-18
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-11
• Last Update Posted: 2016-04-12

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