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

NCT ID: NCT00241020

Last Updated: 2016-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2005-10-31

Brief Summary

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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

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Conditions

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Advanced Hepatocellular Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Octreotide

Group Type EXPERIMENTAL

Octreotide

Intervention Type DRUG

Interventions

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Octreotide

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Other Identifiers

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CSMS995BFR04

Identifier Type: -

Identifier Source: org_study_id

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