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


Phase 3
18 Years
N/A
Not Enrolling
Both
Advanced Hepatocellular Carcinoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall Survival

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

CSMS995BFR04

NCT ID:

NCT00241020

Start Date:

June 2002

Completion Date:

March 2008

Related Keywords:

  • Advanced Hepatocellular Carcinoma
  • hepatocellular carcinoma
  • Octreotide
  • Carcinoma
  • Carcinoma, Hepatocellular

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